Darr Feedlot Inc 4/30/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Kansas City District Southwest Region 11630 W. 80th Street Lenexa, Kansas 66214

April 30, 2010

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

WARNING LETTER

Ref. KAN 2010-04

 

Alan J. Svajgr, President

Darr Feedlots Inc.

1816 Ave H

Cozad, Nebraska 69130

 

Dear Mr. Svajgr:

On May 13-14, 2009, an inspection of your medicated feed mills located at Darr Feedlot, Inc. (North), 42826 Road 759, Cozad, Nebraska 69130 (Darr North) and Darr Feedlot, Inc. (South), 75429 Road 424, Cozad, Nebraska 69130 (Darr South), was conducted by a Food and Drug Administration (FDA) investigator and an inspector from the Nebraska Department of Agriculture on behalf of the FDA. On December 15-17, 2009, another inspection of Darr North and records from Darr South was conducted by an FDA investigator. These inspections documented the use of new animal drugs chlortetracycline and monensin in combination in cattle feed, contrary to the New Animal Drug Application (NADA) approvals for these drugs (see 21 CFR 558.128 and 21 CFR 558.355 for approved uses of chlortetracycline and monensin, respectively, in cattle feed). When combined in cattle feed, these drugs are unsafe within the meaning of section 512(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. §360b(a)(1)(A)], and adulterated within the meaning section 501(a)(5) of the Act, 21 U.S.C. § 351(a)(5).Further, the feed bearing such drugs is unsafe within the meaning of section 512(a)(2)(B) of the Act, [21 U.S.C. 360b(a)(2)(B)], and adulterated within the meaning of section 501(a)(6) of the Act, [21 U.S.C. §351(a)(6)]. In addition, the May 13-14, 2009, inspection documented significant deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds Title 21, Code of Federal Regulations, Part 225 (21 C.F.R. 225). These deviations cause the medicated feed to be adulterated within the meaning of section 501(a)(2)(B) of the Act, [21 U.S.C. § 351(a)(2)(B)].

Our investigation found:

• The use of the drugs chlortetracycline and monensin in combination which are not approved to be used in combination in cattle feed. For example, during the May 13-14, 2009, inspection of Darr North, our investigation found that the facility had manufactured the following loads of an unapproved combination of chlortetracycline and monensin:

o in Load #(b)(4), ration (b)(4) on (b)(4)

o in Load #(b)(4), ration (b)(4) on (b)(4)

o in Load #(b)(4), ration (b)(4) on (b)(4)

o in Load #(b)(4), ration (b)(4) on (b)(4)

o in Load #(b)(4), ration (b)(4) on (b)(4)

o in Load #(b)(4), ration (b)(4) on (b)(4)

During the May 13-14, 2009, inspection of Darr South, our investigation found that the facility had manufactured the following loads of an unapproved combination of chlortetracycline and monensin in medicated feed:

o in Load #(b)(4), ration (b)(4) on (b)(4)

o in Load #(b)(4), ration (b)(4) on (b)(4)

o in Load #(b)(4), ration (b)(4) on (b)(4)

o in Load #(b)(4), ration (b)(4) on (b)(4)

Additionally, during the December 15-17, 2009, inspection of Darr North and records from Darr South, our investigation found that both Darr North and Darr South had manufactured several loads of an unapproved combination of chlortetracycline and monensin in medicated feed between May 21, 2009 and June 5, 2009.

• Failure to establish and maintain adequate procedures for the identification and inventory control, including use, of all Type A medicated articles used in the manufacture of medicated feeds. [21 C.F.R. 225.142] For Example, at the North and South facilities, our investigation found on May 13, 2009, different lots of Type A medicated articles are mixed together in the micro machines without recording the lot numbers and therefore the identity of the drugs is lost.

The above is not intended as an all-inclusive list of deficiencies at your facility. As a manufacturer of medicated feeds, you are responsible for assuring your overall operation and the products you manufacture and distribute are in compliance with the Act and implementing regulations.

You should take prompt action to correct the noted violations, and you should establish procedures whereby such violations do not recur. Failure to effect prompt and permanent corrective actions may result in regulatory and/or administrative sanctions. These sanctions include, but are not limited to, seizure, injunction, civil, and criminal penalties. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies in your operations.

On June 24, 2009, we received your response to the FDA-483 issued on May 14, 2009. On January 19, 2010, we received your response to the FDA-483 issued on December 17, 2009. However, the responses were insufficient. We note that you continued to manufacture an unapproved combination of chlortetracycline and monensin in medicated feed after receiving the FDA-483 issued on May, 14, 2009.

You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to achieve and maintain compliance with the regulations. Your response should include an explanation of each step being taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made. Please send your response to Danial S. Hutchison, Compliance Officer, at the above address.

Sincerely,

/s/

John W. Thorsky

District Director

Kansas City District

-

Vision Pharm, LLC 4/29/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Southeast Region 555 Winderley Place Suite 200 Maitland, Florida 32751

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

WARNING LETTER

FLA-10-17

 

April 29, 2010

 

Sander S. Busman

President & Chief Executive Officer

Vision Pharma, LLC

9180 Estero Park Commons Boulevard

Unit 1

Estero, FL 33928

Dear Mr. Busman:

On (b)(4) FDA issued a warning letter to (b)(4). Inc. (b)(4) (copy attached). As explained more fully in that (b)(4), certain drug products that (b)(4) has manufactured are new drugs that lack approved applications as required under the Federal Food, Drug, and Cosmetic Act (the Act). (b)(4) (b)(4). These drug products include, but are not necessarily limited to:

• Colchicine Tablets, 0.6 mg

• Hyoscyamine Sulfate Tablets, USP, 0.125 mg

• Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg

• Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg

The above products are drugs within the meaning of section 201(g) of the Act, [21 U.S.C. § 321(g)] because, as demonstrated by their labeling, they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Further, they are "new drugs" within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331 (d) and 355(a)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)] is in effect for the drug. Based on our information, there are no FDA - approved applications on file for these drug products (b)(4)

Additionally, because the above prescription drug products are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses, as described in 21 C.F.R. § 201.5. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Because the products lack required approved applications, they are not exempt under 21 C.F.R. § 201.115 from the requirements of section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of these products without approved new drug applications violates section 301(a) and (d) of the Act [21 U.S.C. §§ 331(a) and (d)].

Further, as explained in the (b)(4), the above drug products are adulterated, 21 U.S.C. 351(a)(2)(B), and thus your firm may not introduce or deliver them for introduction into interstate commerce, 21 U.S.C. § 331(a).

The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. In particular, violations cited in this letter are not necessarily limited to drug products manufactured by Sunrise and may apply to all drug products that you market without FDA-approved applications. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, and injunction. Other federal agencies may take this (b)(4) into account when considering the award of contracts.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you no longer market the above products, your response should so indicate, including the reasons that, and the date on which, you ceased production.

Your reply should be sent to U.S. Food & Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida, Attn: Winston R. Alejo, Compliance Officer.

 

Sincerely,

/s/

Emma R. Singleton

Director, Florida District

 

 

Enclosure

 

(b)(4)

-

U Okada & Co Ltd 4/29/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	San Francisco District 1431 Harbor Bay Parkway Alameda, CA  94502-7070 Telephone:510/337-6700

VIA UNITED PARCEL SERVICE

 

Our Reference: FEI 2920655

 

April 29, 2010

 

Dexter N. Okada, President

U. Okada & Company, Ltd.

1000 Queen Street

Honolulu, Hawaii 96814

WARNING LETTER

 

Dear Okada:

We inspected your seafood processing facility, U. Okada & Company Ltd., located at 1000 Queen Street, Honolulu, Hawaii, on January 22,25,26,27, and 29, 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21 Code of Federal Regulations, Part 110 (21 CFR Parts 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your histamine forming fish (yellowfin, bonito, albacore, and mahimahi) are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1) You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for "AHI - YELLOWFIN, BIGEYE, ALBACORE, MARLIN - BLUE, STRIPED, WAHOO (ONO), MARI" lists a monitoring procedure (b)(4) at the Storage critical control point (CCP) that is not adequate to control histamine formation. For products that are stored under refrigerated conditions, we recommend a method of continuous monitoring and

recording storage temperature, i.e., a digital time/temperature data logger or a recorder thermometer, with visual check of the instrument at least once per day.

2) Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for "AHI - YELLOWFIN, BIGEYE, ALBACORE, MARLIN - BLUE, STRIPED, WAHOO (ONO), MAHI" at the Receiving CCP to control histamine formation is not appropriate and your corrective action plan at the Storage CCP is not adequate. The corrective action plan listed at the Receiving CCP (b)(4) cannot be accomplished based on your monitoring procedures. There is no means for you to determine the cumulative time that the product temperature (b)(4). Appropriate corrective actions may include rejecting any lot of fish that is received with (b)(4);or alternatively performing histamine testing on a representative number of fish in the lot and rejecting the lot if the histamine levels are greater than or equal to 50 parts per million.

At the Storage CCP, your corrective action plan does not have provisions to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation. For example, you may wish to perform histamine analysis, evaluate the product for time-temperature exposure, destroy the product, or divert it to a non-food use.

3) You must adequately monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b) However, your firm did not monitor key sanitation areas with sufficient frequency to ensure control of:

a) Prevention of cross-contamination from insanitary objects to food - On January 22, 2010, our investigator observed that the plastic barrier between the refrigerator and the docking area/warehouse was filthy. Your employee was seen several times transporting, in a forklift, pallets of fresh, raw tuna fish through this passage, where the plastic barrier came in direct contact with the fish. Much of the tuna is sashimi grade and intended for raw consumption.

b) Protection of food, food packaging material, and food contact surfaces from adulteration - On January 22, 2010, our investigator observed that a shipment of tuna fish was directly on the floor of your refrigerated truck when it arrived.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the U.S. Food and Drug Administration, Attention: Ms, Erlinda N. Figueroa, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have questions regarding any issue in this letter, please contact Ms. Figueroa at (510) 337-6795.

 

Sincerely,

/s/

Darlene B. Almogela

Acting District Director

San Francisco District

-

Olsen Fish Company 4/29/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7192 FAX: (612) 334-4142

April 29, 2010

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 

Refer to MIN 10 - 14

Christopher D. Dorff
President
Olsen Fish Company
2125 N. Second Street
Minneapolis, Minnesota 55411

Dear Mr. Dorff:

We inspected your seafood processing facility located at 2115 N. Second Street, Minneapolis, Minnesota, on December 7,8,9, 11, 2009. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 and 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123 renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your pickled herring products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a) and (b). However your firm does not have a HACCP plan for refrigerated ready-to-eat herring in wine sauce packaged in glass containers and refrigerated ready-to-eat herring in cream sauce packaged in glass containers received as finished products to control the food safety hazards of scombrotoxin (histamine) formation, and pathogen growth and toxin formation.

2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plans for Herring in Wine Sauce and Cream Style Pickled Herring do not list the critical control point of packaging for controlling the food safety hazards of scombrotoxin (histamine) formation, and pathogen growth and toxin formation.

Specifically, during your inspection, the investigator observed packaging of herring in wine sauce in your refrigerated processing room. The investigator observed this packaging step of the herring in wine sauce to be approximately (b)(4) or longer, with some in-process fish product held (b)(4). Exposing the product to elevated temperatures for extended time periods poses a risk for pathogen growth and potential toxin development. During your finished herring packaging, the product may be in the processing room for cumulative extended periods of time; therefore, the packaging step must be controlled to prevent the food safety hazards of pathogen growth and toxin formation. We recommend monitoring the temperature of the processing room for the duration of the packaging time period.

3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plans for Herring in Wine Sauce and Cream Style Pickled Herring, list a critical limit ("(b)(4)") at the receiving, pre-brine herring, and storage of raw material and finished product critical control points. Additionally, for the Cream Style Pickled Herring HACCP plan, the finishing brine critical control point is not adequate to control pathogen growth and toxin production, including toxin production by Clostridium botulinum. For example, since the HACCP plan lists that (b)(4) will be monitored at these critical control points, a specific maximum (b)(4) value is necessary as the (b)(4) critical limit listed in the plan.

4. You must implement the record keeping system that you listed in your HACCP plans for Herring in Wine Sauce and Cream Style Pickled Herring to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record daily visual review/monitoring of the time temperature data logger at the following critical control points to control histamine formation and pathogen growth listed in your HACCP plans for Pickled Herring in Wine Sauce and Cream Style Pickled Herring: pre-brine herring; storage of raw material and finished product; and additionally for the Cream Style Pickled Herring, the finishing brine critical control point.

5. Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your Herring in Wine Sauce and Cream Style Pickled Herring list inappropriate corrective action procedures. Specifically:

A. At the receiving critical control point, the listed corrective action, "(b)(4)," is not appropriate since it allows acceptance of product exposed to high temperatures that can cause pathogens to grow in less than (b)(4) hours.
 

B. At the pre-brine herring, and storage of raw material and finished product critical control points, and additionally for Cream Style Pickled Herring at the finishing brine critical control point, the listed corrective action is: "(b)(4)" This is not appropriate since it allows distribution of product exposed to high temperatures that can cause pathogens to grow in less than hours.

C. At the pre-brine herring critical control point a corrective action listed is "(b)(4)"; however, the corrective action does not address the disposition of the product itself.

D. At the receiving, pre-brine herring, and storage of raw material and finished product, the listed corrective actions do not address the cause of the deviation per 21 CFR 123.7(b)(2).

E. For Cream Style Pickled Herring, at the finishing brine critical control point, the corrective action does not address the cause of the deviation per 21 CFR 123.7(b)(2).

6. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, and exclusion of pests, with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 110 as evidenced by the following observations made during the inspection:
 

A. Condition and cleanliness of food contact surfaces

i. The Line #3 incline conveyor contained product following cleaning and sanitizing.

B. Prevention of cross-contamination

i. Coriander and spices were on the PVC nozzle for the finishing brine on line #3 following cleaning and sanitizing.

ii. Control box for Line #3 was covered with a plastic bag that contained old product build-up following cleaning and sanitizing.

iii. The spice container was encrusted with debris and what appeared to be mold.

iv. An employee cleaned and sanitized a stainless steel tote, then picked up a screw plug from the floor and placed it into the port of the tote without cleaning and sanitizing the plug first.

v. An employee handled a garbage can while wearing gloves and an apron. He changed his gloves without washing his hands or apron, he then returned to filling containers with finishing brine.

vi. An employee cleaned the floor drain screen and then replaced towels that come in contact with the brined herring without cleaning and sanitizing his gloves.

vii. A container of sour cream being used to prepare cream sauce for pickled herring was observed to be stored on the floor. An employee handled the container of cream sauce, touching the
surface that had been in contact with the floor. He then handscraped and mixed the cream sauce without cleaning and sanitizing his gloves.

viii. A rusty metal blade cutter was used to open bags of onions.

ix. The finishing brine lines directly overhead of the bulk packaging area for line #3 had debris on them.

C. Maintenance of hand washing, hand sanitizing, and toilet facilities

i. There were no hand towels available in the women's restroom on 12/7/09.

D. Protection from adulterants

i. The copper water line directly over the open port of the finishing tank was covered with an oxidation-like buildup.

E. Proper labeling, storage and use of toxic compounds

i. Ammonium chloride sanitizer was used at a concentration of 400 ppm on food contact surfaces without rinsing.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/ or enjoin your firm from operating.

You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Rebecca L. Caulfield, Compliance Officer, at the address on this letterhead. If you have questions regarding any issues in this letter, please contact Ms. Caulfield at (612)758-7194.

Sincerely,
/S/

Cheryl A. Bigham
Acting Director
Minneapolis District

 

xc: Paul Buhl
President
Noon Hour Food Products, Inc.
215 N. Des Plaines
Chicago, Illinois 60661

-

Olsen Fish Company Close out letter

• Olsen Fish Company Close out letter

-

-

Malda, Jeff 4/29/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New York District Food & Drug Administration 158-15 Liberty Avenue Jamaica, NY 11433

April 29, 2010

 

WARNING LETTER NYK-2010-13

 

VIA UPS

 

Jeffrey T. Maida, Owner
2574 Ira StationRoad
Cato, New York 13033-9505

Dear Mr. Malda:

On March 2 and March 5, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2574 Ira Station Road, Cato, New York 13033-9505. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act [21 U.S.C. 342(a)(2)(C)(ii)), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act [21 U.S.C. 360b). Further, under section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)], a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about June 16, 2009, you sold a bob veal calf, identified with (b)(4) for slaughter as food. On or about June 17, 2009, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of florfenicol at 4.40 parts per million (ppm) in the liver and 0.73 ppm in the muscle tissue. FDA has not established a tolerance for residues of florfenicol in the edible tissues of veal calves. The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act [21 U.S.C. 342(a)(2)(C)(ii)).

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain treatment records and segregate treated animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C.342(a)(4)].

We also found that you adulterated the new animal drug florfenicol (b)(4), (b)(4). Specifically, our investigation revealed that you did not use (b)(4) as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See Title 21, Code of Federal Regulations, Section 530.3(a) (21 C.F.R. 530.3(a)).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act [21 U.S.C. 360b(a)(4) and (5)], and 21 C.F.R. Part. 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.

Our investigation found that you administered florfenicol in a class of animal (veal calf) not set forth in the approved labeling and you did so without following the extralabel use directions of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use of florfenicol resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the Act [21 U.S.C. 360b(a)], and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)].

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 541-0324 or Email at dean.rugnetta@fda.hhs.gov.

Sincerely yours,

/s/

Ronald M. Pace
District Director
New York District

Enclosure:
21 CFR Part 530

cc: Dr. John P. Huntley, Director
Division of Animal lndustry
New York State Department of Agriculture & Markets
10 B Airline Drive
Albany, New York 12235

cc: (b)(4)

-

L. Perrigo Company 4/29/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139

WARNING LETTER
2010-DT-11

April 29, 2010

VIA UPS

Joseph C. Papa
President and Chief Executive Officer
L. Perrigo Company
515 Eastern Avenue
Allegan, Michigan 49010

Dear Mr. Papa:

During our November 17, 2009 to January 14, 2010 inspection of your pharmaceutical manufacturing facility, L. Perrigo Company located at 515 Eastern Avenue, Allegan, Michigan, investigators from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

We have reviewed your firm's response of February 1, 2010, and note that it lacks sufficient corrective actions.

Specific violations observed during the inspection include, but are not limited, to the following:

1. Your firm failed to reject drug products failing to meet established standards or specifications and any other relevant quality control criteria [21 C.F.R. § 211.165(f)].

For example, your firm failed to reject a lot of lbuprofen Tablets 200 mg (lot 9BE1961) that was contaminated with metal shavings due to an equipment failure. Although your firm segregated a portion of the lot that was affected, you released and shipped a subportion of that segregated lot, resulting in a recall of the entire lot.

2. Your firm failed to thoroughly investigate the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed and extend investigations to other batches of the same drug product and other drug products that may have been associated with the specific failure [21 C.F.R. § 211.192].

For example, your firm did not thoroughly investigate possible foreign tablet contamination in your filling equipment. After finding a brown, round Ibuprofen tablet (lot 8ME1624) in a lot of brown, oval Ibuprofen caplets (lot 8ME1731), you did not inspect the lot of orange, round Ibuprofen tablets (lot 8ME1728) that was packaged between lot 8MEl624 and lot 8ME1731. Without extending your investigation to lot 8MEI728, there is no assurance that this lot was not also contaminated.

Your response is inadequate it that it neither provides scientific rationale for excluding lot 8ME1728 from your investigation, nor does it address examination of any remaining product. Please comment.

3. Your quality control unit (QCD) failed to follow written procedures [21 C.F.R. § 211.22(d)]. For example:

a. Your QCD failed to follow SOP (b)(4) with regard to editing and verifying label content for Cherry Flavored Milk of Magnesia. Failure to follow your written procedure resulted in release of mislabeled product, which you recalled. This recall, which was designated as Class II, was initiated on November 23, 2009.

b. Your QCD failed to follow SOP (b)(4) with regard to verifying the accuracy of label ingredient disclosure quantities of magnesium and calcium in Regular and Mint Flavored Milk of Magnesia and identifying incorrect values as changes from expected label specifications. Failure to follow your written procedure resulted in release of mislabeled product, which you recalled. This recall, which was designated as Class III, was initiated on December 7, 2009.

FDA investigators documented your firm's failure to follow Standard Operating Procedures (SOPs) during the last three FDA inspections, as well as in other inspections since 1998. Although your February 1, 2010 response acknowledges the procedural errors and recalls in both examples above, your response does not provide the corrective actions your firm plans to take to prevent reoccurrences in the future.

4. Your firm failed to adequately inspect the packaging and labeling facilities immediately before use to assure that all drug products have been removed from previous operations [21 C.F.R. § 211.130(e)]. For example:

a. Your firm failed to adequately inspect packaging equipment, as evidenced by foreign tablets observed by film packaging employees. Specifically, you did not remove all Ibuprofen tablets from a prior lot before packaging and labeling Ibuprofen caplets on December 10, 2008 (lot 8ME1731) and February 13, 2009 (lot 9BE1926).

b. Your firm tailed to inspect packaging equipment, as evidenced by foreign tablets observed by firm packaging employees. Specifically, you did not remove all Ibuprofen orange caplets before beginning packaging and labeling of Ibuprofen brown caplets (lot 9DE1562) on April 10, 2009.

Your response states that you revised SOP (b)(4) in December 2009. You also commit to conduct deviation investigations, ensure appropriate corrective actions, initiate improvements to reduce or eliminate potential "hiding places" for drug product including equipment modifications, and provide updates on all such improvements to the Detroit District. Please provide all equipment modifications your firm plans to make to prevent reoccurrence of this issue; also thoroughly explain the rationale for your equipment modification decisions. In addition, please include a timeline for the completion of these modifications.

Your firm has had an ongoing program since 2005 to address mixups. However, your firm continues to receive complaints regarding this issue, and despite past assurances that previous enhancements would control this problem, deviations continue. Your firm failed to implement sustainable corrective actions to prevent mixups as well as other continuing problems. As a result, we have concerns regarding the failure of your firm, including the QCU, to act proactively to ensure compliance with SOPs and the CGMP regulations. Please indicate how you intend to implement, support, and sustain a comprehensive quality system that is consistent with CGMP. Be advised that FDA expects that your corporate management will undertake a comprehensive evaluation of manufacturing operations to ensure compliance with CGMP.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected. FDA may re-inspect to verify corrective actions have been completed.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Additionally, your response should state if you no longer manufacture or distribute the drug product(s) manufactured at this facility, and provide the date(s) and reason(s) you ceased production.

Your reply should be sent to the following address: U.S. Food and Drug Administration, c/o Judith A. Putz, Compliance Officer, 300 River Place, Suite 5900, Detroit, Michigan 48207.

Sincerely,

/S/
Joann M. Givens
District Director
Detroit District Office
 

-

Close out Letter

• L. Perrigo Company Close out Letter 5/9/11

-

-

Martin Feed Lot 4/27/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863

 

April 27, 2010

WARNING LETTER

CHI-06-10

CERTIFIED MAIL
RETURN ADDRESS REQUESTED

Michael D. Martin, Owner
Martin Feed Lot
1010 Mitchellsville Road
Harrisburg, Illinois 62946

Dear Mr. Martin:

On December 29, 2009, and January 5, 2010, the U.S Food and Drug Administration (FDA) conducted an investigation of your feed lot operation located at 1010 Mitchellsville Road, Harrisburg Illinois. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under Section 402(a)(2)(C)(ii) of the Act [21 U.S.C. 342(a)(2)(C)(ii)], a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under Section 512 of the Act, 21 U.S.C. 360b. Further, under Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)], a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about July 7, 2009, you sold a beef heifer, identified with back tag (b)(4) for slaughter as food. On or about July 10, 2009, slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS), analysis of tissue samples collected from this animal identified the presence of sulfamethazine at 38.855 parts per million (ppm) in liver tissue and the presence of flunixin at 0.1781 ppm in liver tissue. FDA has established a tolerance of 0.1 ppm for negligible residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.670 [21 CFR 556.670] and a tolerance of 0.125 ppm (or 125 parts per billion) for residues of flunixin in the liver (the target tissue) of cattle as codified in 21 CFR 556.286. The presence of these drugs in edible tissues from this animal in these amounts causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act [21 U.S.C. 342(a)(2)(C)(ii)]. Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)].

We also found that you adulterated the new animal drug flunixin. Specifically, our investigation revealed that you did not use flunixin as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 CFR 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with Sections 512(a)(4) and (5) of the Act [21 U.S.C. 360b(a)(4) and (5)], and 21 CFR Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.

Our investigation found that you administered flunixin to a beef heifer, identified with back tag (b)(4) without following the route of administration as indicated in its approved labeling. Your extralabel use of flunixin was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(d). Because your extralabel use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused the drug to be unsafe under Section 512(a) of the Act, 21 U.S.C. 360b(a), and adulterated within the meaning of Section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5).

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 15 working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Richard Harrison, Director, Compliance Branch, at the address of the letterhead. If you have any questions regarding this letter, please contact Mr. Richard Harrison at 312-596-4220 or via e-mail at RICHARD.HARRISON@FDA.HHS.GOV.

 

Sincerely,
/S/
Scott J. MacIntire
District Director
Enclosure: FDA-483 dated July 30, 2009

cc: (b)(4)

Illinois Department of Agriculture
Bureau of Animal Health
State Fairgrounds - P.O. Box 19281
Springfield, Illinois 62794-9281

United States Department of Agriculture
Food Safety and Inspection Service
Office of Policy, Program and Employee Development
1299 Farnam Street, Suite 300
Omaha, Nebraska 68102
Attention: Residue Staff

-

Close Out Letter

• Martin Feed Lot - Close Out Letter 9/14/11

-

-

La Estrellita Enterprises Incorporated 4/26/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Denver District Office Building 20 - Denver Federal Center P.O. Box 25087 Denver, Colorado 80225-0087 TELEPHONE: 303-236-3000

April 26, 2010

 

WARNING LETTER

 

VIA UPS PRIORITY

 

John R. Montoya, President/Co-Owner

La Estrellita Enterprises, Inc.

dba La Estrellita Salsa Company

436 W. 915t Circle

Thornton, CO 80260

 

Ref: # DEN-10-11-WL

Dear Mr. Montoya:

The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, La Estrellita Enterprises, Inc. (dba La Estrellita Salsa Company), located at 45 North Main Street, Brighton, Colorado, 80601, on February 18 - 26, 2010. The inspection revealed that you have serious deviations from the Acidified Food regulations [21 Code of Federal Regulations (CFR) Parts 108 and 114]. Failure to comply with all of the requirements of 2l CFR 108.25 and the mandatory portions of part 114 constitutes a prima facie basis for the immediate application of the emergency permit control provisions of Section 404 of the Federal Food, Drug and Cosmetic Act (the Act). In addition, such failure renders your Acidified Food adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)]. Accordingly your firm's acidified food products including your Red Salsa, Hot Green Jalapeno Salsa, and Green Vegetarian Chili products have been packed or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the Acidified Food regulations through links in FDA's home page at http://www.fda.gov. 

We acknowledge receipt of your firm's response to the FDA 483 received on March 19, 2010 and-our comments are included below. We will verify the effectiveness of the your indicated corrections during the next inspection.

The significant violations documented during the inspection include, but are not limited to, the following:

1. Your firm did not employ appropriate quality control procedures to ensure that finished foods do not present a health hazard as required by 21 CFR 114.80(a). Specifically, the pH meter that your firm uses to determine product pH was not standardized with the appropriate pH buffer (pH 4.0) prior to use in determining product pH. Procedures for standardization of pH meters and product pH measurement can be found in 21 CFR 114.90. You indicate in your response that you now have the pH 4.0 buffer. We will verify the adequacy of your product pH measurements during the next inspection.

2. 21 CFR 108.25(c)(1) requires that a commercial processor engaged in the manufacture, processing or packing of acidified foods, register and file information with FDA including the name of the establishment, principal place of business, the location of each establishment in which processing is carried on, the processing method in terms of acidity and pH control and a list of foods so processed in each establishment. However, your firm, which manufactures acidified foods, has not registered with FDA in accordance with 21 CFR 108.25(c)(1). More  information on registration and filing can be found in the publication "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods," available at: http://ww.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/

As a commercial processor engaged in the processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide FDA information as to the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). However, your firm has failed to file a scheduled process for the following acidified foods that your firm manufactures: Vegetarian Green Chile (Hot, Medium, and Mild versions), Red Salsa (Hot, Medium, and Mild versions); and Hot Green Jalapeno Salsa.

Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods," available at: http://www.fda.gov/Food/FoodSafety/ProductSpecificInformation/AcidifiedLow-AcidCannedFoods/

3. Your firm failed to have a scheduled process established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods as required by 21 CFR 114.83. Specifically, no scheduled process has been established in accordance with the requirements of 21 CFR 114.83 for the following acidified foods: 

a. Green Vegetarian Chile (Hot, Medium, and Mild versions)

b. Hot Green Jalapeno Salsa

c. Red Salsa (Hot, Medium, and Mild versions)

Your response indicates you planned to meet and discuss your products on 3/19/10 with (b)(4),(b)(6). You will need to obtain the appropriate processing information and register and file processing information with FDA as indicated above for all products that you manufacture that are determined to be acidified foods.

4. Your firm failed to maintain production records of examination of raw materials, packaging materials, finished products, and supplier's guarantees or certificates to verify compliance with FDA regulations and guidelines or actions levels as required by 21 CFR 114.100(a) and 21 CFR 114.100(d). Specifically: No records are maintained documenting examination of raw materials, packaging materials, or finished product evaluations.

We note that your response indicated that you are now adding this to your records requirements. We will verify the adequacy of the above records to comply with the requirements of 21 CFR 114.100(a) and (d) during the next inspection.

5. Your firm failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food-contact surfaces to comply with 21 CFR 110.35(a) and 110.35(b). For example:

a. During cleaning of production equipment, piping between the kettle and filler were not broken down to assure removal of all food debris and burn on residue. In addition, the bottom of the (b)(4) fill reservoir was not broken down to remove build-up of heavy food residue although manufacturer's instructions require break-down as often as necessary to remove food debris.

b. Your chlorine-based sanitizer used to sanitized equipment before use has been determined during at least two of the past three inspections to contain chlorine at a concentration over 200 parts per million (ppm), which could cause the residue to become a food contaminant.

On other occasions during our inspection, your chlorine-based sanitizer measured at 10 ppm. Sanitizing solution with a sanitizer concentration below manufacturer's label recommendations may prevent removal of micro-organisms of a public health concern.

We note that your response indicated, concerning chlorine measurement, that you are now measuring 80 ppm chlorine in the sanitizer. We will verify the adequacy of your sanitizer chlorine concentrations during the next inspection.

6. Your firm has not prepared and maintained current procedures for recalling products that may be injurious to health, identifying, collecting, warehousing and controlling products, determining the effectiveness of recalls, notifying FDA, and implementing recall programs to comply with 21 CFR 108.25(e). Specifically, you have not developed a formal recall procedure to identify products that may be injurious to health: You also fail to maintain records that identify initial distribution of finished product in the event your firm needs to conduct a recall.

We note that your response indicated that you are now recording which batches go to each distributor. We will verify the adequacy of the above records in meeting the requirements of 21 CFR 108.25(e) during the next inspection.

We acknowledge receipt of your written response to the FDA-483, list of inspectional observations, issued to you at the close of the recent inspection. However, though the response appears to address our concerns, it is inadequate in that you have not provided documentation to confirm the steps you have taken or are taking to correct the deficiencies. For example, you have not provided pictures of repaired floor tiles or payment receipts to service persons; copies of monitoring records showing cleaning of piping or temperature achieved during processing of acidified products; and/or a receipt showing the purchase of pH 4.0 buffer. Further, you have made commitments to correct the deficiencies noted in this Warning Letter during past inspections and meetings, but you have failed to follow through with the appropriate corrective action.

We acknowledge corrective actions were taken to some noted deficiencies at the time of the inspection, including but not limited to, restoration of running water in restrooms and removal of unused equipment and debris from the side of the walk-in freezer.

The above violations are not intended to be an all-inclusive list of violations in your plant. Other violations can subject your food products to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations (specifically 21 CFR Parts 110 and 114).

You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.

We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term, corrective action, such as evidence that you are working with a process authority or your scheduled process has been filed with the FDA. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.

Your written response should be directed to the U.S. food and Drug Administration, Attention: Nancy G. Schmidt, Compliance Officer, at the above address. If you have questions about this letter, please contact Ms. Schmidt at (303) 236-3046.

Sincerely,

/s/

H. Thomas Warwick, Jr.

Denver District Director

-

Ephraim McDowell Regional Medical Center IRB 4/26/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Silver Spring, MD 20993

WARNING LETTER

UPS

 

          Ref: 10-HFD-45-04-03

Ms. Vicki Darnell

President and Chief Executive Officer

Ephraim McDowell Regional Medical Center

217 S.3^rd St.

Danville, KY 40422

Dear Ms. Darnell:

Between December 21, 2009 and January 6, 2010, Ms. Karen Bryerton Cooper, and Mr. Craig Rybus, representing the Food and Drug Administration (FDA), inspected the Institutional Review Board (IRB) at the Ephraim McDowell Regional Medical Center. The purpose of this inspection was to determine whether the IRB procedures for the protection of human subjects complied with Title 21 of the Code of Federal Regulations (CFR), parts 50 and 56. These regulations apply to clinical investigations of products regulated by FDA. We are aware that at the conclusion of the inspection, our investigators presented and discussed with Dr. Joan Haltom, Pharmacy Director, Ms. (b)(6), Study Coordinator, and Ms. (b)(6), Pharmacy Operations Clerk, a Form FDA 483, Inspectional Observations.

From our review of the establishment inspection report and the documents submitted with that report, we conclude that the IRB did not adhere to the applicable statutory requirements and FDA regulations governing the protection of human subjects. We acknowledge Dr. Thomas Baeker, IRB Chairman’s written response dated February 3, 2010, to the Form FDA 483. However, because this written response was received more than fifteen business days after the Form FDA 483 was issued, the response has not been considered. We plan to evaluate Dr. Baeker’s written response to the Form FDA 483 along with any other written material provided as the direct response to this letter.

We wish to emphasize the following:

1. The IRB failed to prepare and maintain written procedures for the IRB and failed to follow written procedures as required by 21 CFR 56.108(a) and (b) [21 CFR 56.115(a)(6)].

In order to fulfill the requirements of the IRB regulations, each IRB must prepare, maintain, and follow written procedures describing IRB functions and operations specified in the regulations.

Our inspection revealed that the IRB failed to prepare and maintain, and therefore did not follow, adequate written procedures for the IRB functions and operations. The IRB’s Organizational Policy document, the only policy identified by the IRB staff as being in effect, and the only one examined by FDA that is signed, does not include the following:

a. Written procedures for conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution [21 CFR 56.108(a)(1)]. We acknowledge some limited references in the Organizational Policy document to certain aspects of review, such as the need for majority vote, and identification of quorum; however, this is not sufficient to address the requirements of this provision.

b. Written procedures for determining which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review [21 CFR 56.108(a)(2)].

c. Written procedures for ensuring prompt reporting to the IRB of changes in research activities [21 CFR 56.108(a)(3)].

d. Written procedures for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects [21 CFR 56.108(a)(4)].

e. Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any unanticipated problems involving risks to human subjects or others [21 CFR 56.108(b)(1)].

f. Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB [21 CFR 56.108(b)(2)].

g. Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any suspension or termination of IRB approval [21 CFR 56.108(b)(3)].

2. The IRB failed to prepare and maintain a list of IRB members identified by name; earned degrees; representative capacity; indications of experience sufficient to describe each member’s chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution [21 CFR 56.115(a)(5)].

As part of preparing adequate IRB records, the IRB is required to maintain a list of IRB members in accordance with the regulations.

Our inspection revealed that the IRB failed to prepare and maintain an adequate list of IRB members in compliance with the regulations. None of the IRB membership rosters reviewed by the FDA Investigators (years 2006-2007, years 2007-2008, and years 2008-2009) include each IRB member’s earned degree, representative capacity, indications of experience sufficient to describe the member’s chief anticipated contributions to the IRB deliberations, or any employment or other relationship between the member and the institution.

We note that this finding is a repeat issue from the previous inspection of the Ephraim McDowell Regional Medical Center IRB conducted in January 2004.

3. The IRB failed to review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas [21 CFR 56.108(c)].

Except when an expedited review procedure is used, the IRB may only review proposed research at convened meetings at which a majority of the IRB members (i.e., a quorum) is present, including at least one member whose primary concerns are in nonscientific areas.

Our inspection revealed that the IRB reviewed and approved research at meetings at which a majority of the IRB members was not present. For example:

a. Meeting minutes dated April 25, 2007 indicate that eight IRB members were present at the meeting, during which research was reviewed and approved. The IRB membership roster for the noted time period included seventeen members, meaning that at least nine members were required to be present in order to have a quorum.

b. Meeting minutes dated October 28, 2009 indicate that eight IRB members were present at the meeting, during which research was reviewed and approved. The IRB membership roster for the noted time period included seventeen members, meaning that at least nine members were required to be present in order to have a quorum.

The deficiencies found in the IRB membership rosters discussed in item #2 above, made it difficult to determine whether the required nonscientist was present at all convened IRB meetings when reviewing IRB meeting minutes.

We note that this finding is a repeat issue from the previous inspection of the Ephraim McDowell Regional Medical Center IRB conducted in January 2004.

4. The IRB failed to notify investigators and the institution in writing of its decision to approve or disapprove proposed research activities, or of modifications required to secure IRB approval of the research activity [21 CFR 56.109(e)].

The IRB is required to notify investigators and the institution in writing of its decision to approve or disapprove proposed research, or of modifications required to secure IRB approval.

The IRB Organizational Policy document states that the minutes from the IRB will be forwarded to the Medical Executive Committee. Our inspection revealed that the IRB meeting minutes are not being forwarded to the Medical Executive Committee. There is no indication that IRB is notifying the institution in writing of its findings and actions.

This letter is not intended to be an all-inclusive list of deficiencies for the protocols reviewed and approved by the IRB. It is your responsibility to ensure that the Ephraim McDowell Regional Medical Center IRB’s practices and procedures comply fully with all applicable statutes and regulations.

Within fifteen (15) business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Your written response should include any documentation necessary to show that full and adequate correction will be achieved. Please include the projected completion dates for each action to be accomplished. Failure to adequately and promptly explain the violations noted above may result in regulatory action without further notice. If you believe that Dr. Baeker’s written response to the Form FDA 483 dated February 3, 2010 fully explains the actions you have taken to prevent similar violations in the future, please communicate that to us in writing within fifteen (15) business days. As noted above, we plan to evaluate your written response to the Form FDA 483 along with any other written material provided as a direct response to this Warning Letter. You may reference the written response dated February 3, 2010 in your response to this letter. 

We recommend that you visit the following FDA web page for information on human subject protections that may assist you in your efforts to bring the IRB into compliance with FDA regulations:

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm

We appreciate the cooperation shown to FDA Investigators Bryerton Cooper and Rybus during the inspection. If you have any questions, please contact Kevin Prohaska, D.O., M.P.H., at 301-796-3707; FAX 301-847-8748. Your written response and any pertinent documentation should be addressed to:

Kevin Prohaska, D.O., M.P.H.

Acting Human Subjects Protections Team Lead

Division of Scientific Investigations

Office of Compliance

Center for Drug Evaluation and Research

Food and Drug Administration

Bldg 51, Room 5356

10903 New Hampshire Avenue

Silver Spring, MD 20993

 

Sincerely,

/S/

Leslie K. Ball, M.D.

Director

Division of Scientific Investigations

Office of Compliance

Center for Drug Evaluation and Research

Food and Drug Administration

 

cc: Dr. Thomas Baeker

IRB Chairman

Ephraim McDowell Regional Medical Center

217 S.3^rd St.

Danville, KY 40422

Dr. Joan Haltom

Pharmacy Director

Ephraim McDowell Regional Medical Center

217 S.3^rd St.

Danville, KY 40422

Ms. (b)(6)

Study Coordinator

Ephraim McDowell Regional Medical Center

217 S.3^rd St.

Danville, KY 40422

Ms. (b)(6)

Pharmacy Operations Clerk

Ephraim McDowell Regional Medical Center

217 S.3^rd St.

Danville, KY 40422

Dr. (b)(6)

Pharmacist

Ephraim McDowell Regional Medical Center

217 S.3^rd St.

Danville, KY 40422

-

Accurate Set Inc. 4/26/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Central Region Waterview Corporate Center 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054

Telephone (973) 331-4906

April 26, 2010

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

WARNING LETTER

Mr. Cornell Adams

President

Accurate Set Inc.

1199 Broad Street

Newark, NJ 07114

10-NWJ-09

Dear Mr. Adams:

During an inspection of your firm located in Newark, New Jersey, on October 30, 2009 through November 13, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer, repacker, and distributor for Setacure (Self curing Polymer), Heat and Self Cure Tooth Shade Acrylic Powders, 20-minute Cure Acrylic (Self Cure), Setatone Extra-Hard Crown and Bridge Monomers, Setatone Crown and Bridge Monomers, and Temporary Acrylic for Crown and Bridge. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act ("the Act") [21 U.S.C. § 321(h)] these products are devices because there intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

At the close of the inspection, a FDA Investigator discussed with you objectionable conditions observed during the inspection. A Form FDA-483 was issued. We received no written response to Form FDA-483 that was issued to you.

The Act requires manufacturers of medical devices to obtain marketing clearance or approval from FDA before they may offer them up for sale. This requirement protects the public health by helping to ensure that new medical devices are shown to be either both safe and effective or substantially equivalent to other devices already legally marketed in the United States. The FDA inspection revealed that your devices are adulterated within the meaning of section 501(h) of the Act [21 U.S.C. § 351(h)] in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA) as required by 21 CFR § 820.100(a).

Specifically, your firm's Quality System Procedures (8.53 Corrective Action, dated March 16, 2004 & 8.53 Preventive Action, dated March 22, 2004) do not include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems.

2. Failure to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, and failure to maintain records of an investigation as required by 21 CFR § 820.198(c), (d), and (e).

Specifically, your complaint record for the Heat Cure Acrylic did not include information to show whether an investigation was conducted, what caused the material to not set properly, and whether any CAPA was implemented as required by your written procedure for handling complaints, dated April 1, 2004.

3. Failure to establish and maintain procedures that address the need to evaluate and document an investigation in order to control product that does not conform to specified requirements as required by 21 CFR § 820.90(a). Specifically, your written procedure for Control of Nonconforming Product (Quality System Procedure 8.3, dated March 22, 2004) does not require an evaluation of the need for a documented investigation for nonconforming products.

4. Failure to maintain device history records (DHR's) as required by 21 CFR § 820.184. Specifically, your firm has failed to implement procedure 7.1-2, Device History Record, dated March 22, 2004, in order to ensure that the device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the Quality System regulation. For example, there was a lack of device history records for the one pound 20 minute Cure Acrylic (self cure) powder and two eight-ounce Setacure Monomer, Lot # 4272009, packed on April 27,2009.



5. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system as required by 21 CFR § 820.22. Specifically, quality audits were not conducted at sufficient regular intervals, as prescribed by your Internal Audit Procedure, 8.22, dated March 22, 2004, in order to verify that your quality system is effective in fulfilling your quality system objectives. Your internal audit procedure specifies that internal audits are to be scheduled at least (b)(4) or more frequently if the number of corrective actions warrants additional attention to the quality system. However, your firm has not conducted any internal audits since the previous inspection which was conducted on September 23, 2004.

Our inspection also revealed that your Setacure (Self curing Polymer) and Heat and Self Cure Tooth Shade Acrylic Powder devices are adulterated under section 501(f)(1)(B) of the Act [21 U.S.C. 351(f)(1)(B)] because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act [21 U.S.C. 360e(a)] or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act [21 U.S.C. 360j(g)]. These devices are also misbranded under section 502(o) the Act [21 U.S.C. 352(o)] because you did not notify the agency of your intent to introduce these devices into commercial distribution, as required by section 510(k) of the Act [21 U.S.C. 360(k)]. For a device requiring premarket approval, the notification required by section 510(k) of the Act [21 U.S.C. 360(k)] is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that must be submited in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to: Robert J. Maffei, Compliance Officer, U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054. If you have any questions about the content of this letter, please contact Mr. Maffei at 973-331-4906.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA-483 issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance. 

 

Sincerely yours,

/S/

Diana Amador-Toro

District Director

New Jersey District Office

-

St. Jude Medical Atrial Fibrillation Division Inc. 4/23/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	10903 New Hampshire Avenue Silver Spring, MD 20993

APR 23 2010

VIA UPS EXPRESS

Jane J. Song

President

St. Jude Medical, Inc.

Atrial Fibrillation Division

240 Santa Ana Court

Sunnyvale, California 94085

Dear Ms. Song:

During an inspection of your firm located in Sunnyvale, California, on July 9 through July 29, 2009, and after reviewing your firm's website, www.sjmprofessional.com. the Food and Drug Administration (FDA) has learned that your firm is promoting and marketing the Epicorâ„¢ LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device in the United States (U.S.) in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

Under section 201(h) of the Act, the Epicorâ„¢ LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body, 21 U.S.C. 321(h). 

 

FDA cleared the Epicorâ„¢ LP Cardiac Ablation System under premarket notification, K080292 (which includes the UltraWand LP and UltraCinch LP Ablation Devices, the Ablation Control System, connecting cable, and accessories), for the intended use of ablation of cardiac tissue during cardiac surgery.

FDA also approved your investigational device exemption (IDE) application for the Epicorâ„¢ LP Cardiac Ablation System (which includes the UltraWand LP and UltraCinch LP Ablation Devices, the Ablation Control System, connecting cable, and LP Positioning and Sizing Accessory) for the clinical study of a new indication for the treatment of atrial fibrillation, IDE #G060036.

On your website, www.sjmprofessional.com/Products/US/Ablation-Therapy/Epicor-LP-Cardiac-Ablation-System.aspx, you claim:

• "The Epicor LP system is designed specifically to create the critical Cox Maze III lesions entirely epicardially, which helps mitigate risks associated with other cardiac ablation technologies."

• "The Epicor UltraCinch LP Ablation Device ... is designed to safely, effectively and reproducibly create a classic box lesion in a single step."

FDA considers these claims on your website to be promotion of these devices for the treatment of atrial fibrillation. Although the box lesion and Maze lesions are ablation lesions performed on cardiac tissue during cardiac surgery, they are specifically intended to disrupt abnormal electrical conduction to isolate the pulmonary veins in an attempt to terminate a patient's atrial fibrillation. Therefore, FDA considers references to the classic box or Maze cardiac lesions to be synonymous with the treatment of atrial fibrillation.

 

FDA has determined that your activities as the (b)(4) of the clinical study for the Epicorâ„¢ LP Cardiac Ablation System, including its component devices, failed to comply with applicable federal regulations. Our review revealed several violations of Title 21, Code of Federal Regulations (21 C.F.R.) Part 812 .- Investigational Device Exemptions and Section 520(g) (21 U.S.C. 360j(g)) of the Act.

FDA considers the above statements on your website to he promotion of your Epicorâ„¢ L.P Cardiac Ablation System and your Epicor UltraCinch LP Ablation Device that are (b)(4) for the treatment of atrial fibrillation, which is the (b)(4). As a result. you are in violation of FDA's prohibition against promoting an (b)(4) before FDA has approved the device for commercial distribution under 21 CFR XI2.7(a). In addition, you are representing that the Epicor UltraCinch LP Ablation Device is safe or effective for the purposes for which it is (b)(4) in violation of 21 CFR 812.7(d).

The Epicorâ„¢ LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device that are under IDE are adulterated under section 501(i) of the Act 21 USC 351(i), because they are devices for which an exemption has been granted under section 520(g) of the Act for (b)(4), and you have failed to comply with requirements prescribed by or under such section. Failing or refusing to comply with any requirement prescribed under section 520(g) of the Act is a prohibited act. Section 301(q) of the Act, 21 USC 331(q).

 

FDA also has learned that your firm is marketing the Epicorâ„¢ LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device in the U.S. without marketing clearance or approval, in violation or the Act. The Act requires that manufacturers of devices that arc not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.

Your firm's website, www.sjmprofessional.com/Product/US/Ablation-Therapy/Epicor-LP-Cardiac-Ablation-System.aspx. states that the Epicorâ„¢ LP Cardiac Ablation System "is commercially available for use in the United States ...... A review or our records reveals that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law.

Marketing the commercially available Epicorâ„¢ L.P Cardiac Ablation System and Epicor UltraCinch LP Ablation Device for the treatment of atrial fibrillation, represents a major change or modification in the intended use of the devices. 21 CFR 807.81(a)(3)(ii). The commercially available Epicorâ„¢ LP Cardiac Ablation System and Epicor UltraCinch LP Ablation Device are adulterated under section 501(f)(1)(B) of the Act. 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant In section 515(a) of the Act, 21 U.S.C. 360e(a). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b), The kind of information you need to submit in order to obtain approval or clearance for your devices is described on the Internet at www.fda.gov/cdrh/devadvise/3122.html. The FDA will evaluate the information you submit and decide whether your products may he legally marketed.

In addition, FDA reviewed your promotional materials collected during our inspection. Included in the launch kit materials intended to be distributed to St Jude Medical Field Representatives are an Epicor LP Sales Representative Resources CD, an Epicor LP Brochure, and an Epicor LP Spec Sheet.

The Epicor LP Sales Representative Resources CD, intended for the audience of St. Jude Medical field representatives." contains a PowerPoint presentation entitled "Epicorâ„¢ LP Cardiac Ablation System: Positioning: opening new accounts and driving increased utilization," The following slides are included in the presentation:

• Slide 12 of the PowerPoint

o "Give the surgeon a compelling reason to try Epicor"

o "Allows for the creation of it classic box lesion epicardially. on a beating heart and in a single step"

• Slide 13

o The Epicor has the "Ability to complete a full left atrial maze epicardially"

• Slide 16

o "Only Epicor allows surgeons to safely and reliably create the critical left atrial Cox-Maze III lesions without requiring that an atriotomy be performed"

The Epicor LP Brochure and the Epicor LP Spec Sheet, intended for the audience of "physicians and allied healthcare professionals" and "hospital purchasing departments and OR managers," respectively, include claims regarding the Epicor UltraCinch LP Ablation Device, The Brochure claims: "The Epicor UltraCinch LP Ablation Device. . . is designed to safely, effectively and reproducibly create a classic box lesion in a single step," The Spec Sheet claims: "The Epicor UltraCinch LP Abation Device is designed to replicate the classic box lesion, isolating all four pulmonary veins by creating a contiguous lesion."

Please be advised that FDA considers these to be an indication for which the Epicorâ„¢ LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device are being (b)(4) and outside of the cleared intended use of your 510(k). If these promotional materials are distributed, as intended, to "physicians. "allied healthcare professionals," "hospital purchasing departments," or "managers,"  then such promotions and representations of these devices (b)(4) would cause the devices to be adulterated under section 501(i) of the Act and constitute a prohibited act under section 301(q) of the Act. Such claims would also represent a major change or modification in the intended use of these devices that are commercially available pursuant to 21 CFR 807.81(a)(3)(ii). With a significantly modified intended use, these devices that are commercially available would be adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351 (f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act 21 U.S.C. 360e(a). The devices would also he misbranded under section 502(o) the Act. 21 U.S.C. 352(0) because you have not notified the agency of your intent to introduce the device into commercial distribution as required by section 510(k) of the Act. 21 U.S.C. 360(k).

The Office of Compliance requests that St. Jude Medical immediately cease the dissemination of promotional materials the same as or similar to that described above for these devices.

You should take prompt action to correct these violations. Failure to respond to this letter and promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice to you. These actions include but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Epicorâ„¢ LP Cardiac Ablation System and its components comply with each applicable requirement of the Act and FDA implementing regulations. Also, it is your responsibility as a study sponsor to ensure compliance with the Act and applicable regulations.

Within fifteen (15) working days of receiving this letter. please provide written documentation of the actions you have taken or will take to correct these violations and what actions you have taken or will take to prevent the recurrence of similar violations in current or future studies for which you are the study sponsor. Please also list all promotional materials for these devices the same as or similar to that described above, and explain your plan for discontinuing use of such materials. Any submitted corrective action plan must include projected completion dales for each action to be accomplished. If you need more time, let us know why and when you expect to complete your correction. Please direct your response or any questions you may have to:

Melissa Torres, Acting Branch Chief

Cardiac Rhythm and Electrophysiology Devices Branch

Office of Compliance

Center for Devices and Radiological Health

10903 New Hampshire Avenue

WO-66, Room 2040

Silver Spring, MD 20993



Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter does not necessarily address other obligations you have under the law.

Sincerely,

/S/

Timothy A. Ulatowski

Director

Office of Compliance

Center for Devices and

Radiological Health

-