FDA Warning Letters: September 2011

Friday, September 30, 2011

Vitalie Rotaru 9/30/11


Department of Health and Human Services	Public Health Service Food and Drug Administration
	Center for Tobacco Products 9200 Corporate Boulevard Rockville, MD 20850-3229

VIA UPS and VIA Electronic Mail

SEPT 30, 2011

Vitalie Rotaru

Main Street

Modena, New York 12548

sales@discount-cigarettes.us

vrotari@gmail.com

WARNING LETTER

Dear Mr. Rotaru:

The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed your website http://www.discount-cigarettes.us, and determined that your cigarette product(s) listed there are offered for sale to U.S. customers. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).

FDA has determined that several of your products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because you promote them as modified risk tobacco products without an FDA order in effect that permits such promotion. Additionally, FDA has determined that your Kiss Strawberry Superslim, Kiss Fresh Apple Superslim, Esse Aura Green Apple, Esse Aura Pink Strawberry, Richmond Cherry, Aroma Rich Apple, Aroma Rich Rum & Cherry, and Lady Rose Slims cigarettes are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.

You describe products that you offer for sale on your website http://www.discount-cigarettes.us as being light, or some variation thereof, by referring to them as such in product advertising and adding the qualifiers “light,” “Lights,” and “Super Lights” to the product descriptions. Specifically, our review of your website revealed that you offer for sale Pall Mall Blue, L&M Blue Label, and Bond Street Fine cigarettes with the following product descriptions:

“Pall Mall cigarettes [are] currently sold as a Canadian discount brand in Red (full-flavour) and Blue (light).” [emphasis removed]
“Due to new labeling regulations in Europe banning the use of the word ‘lights’ names of some cigarette brands have been changed, i.e. L&M Lights are now L&M Blue Label.”
“Bond Street Fine Cigarettes (Super Lights)”

A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” or “low,” or a similar descriptor, is a “modified risk tobacco product” under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). Because your website uses the descriptor “light,” or some variation thereof, for the above-listed products, the products are modified risk tobacco products. Because these products are offered for sale to U.S. customers without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).

Additionally,our review of your website http://www.discount-cigarettes.us revealed that you offer for sale the following cigarettes, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the product: Kiss Strawberry Superslim, Kiss Fresh Apple Superslim, Esse Aura Green Apple, Esse Aura Pink Strawberry, Richmond Cherry, Aroma Rich Apple, Aroma Rich Rum & Cherry, and Lady Rose Slims. You specifically advertise your Lady Rose Slims cigarettes as “Rose flavor.” Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1 )(A)) provides:

[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice…that is a characterizing flavor of the tobacco product or tobacco smoke.

As of September 22, 2009, cigarettes marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarettes are adulterated.

If, however, these cigarettes do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) as their labeling is false and misleading because it makes the representation that the products contain apple, cherry, rose, rum & cherry, or strawberry as a characterizing flavor of the tobacco products.

You should immediately correct the violations stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. The violations discussed in this letter do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that your tobacco products on this website, or any other websites you own, operate, and/or control, comply with the applicable provisions of the FD&C Act. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for importation into the United States are subject to detention and refusal of admission.

Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative promotion, advertising, sale, and/or distribution of these tobacco products.

Please direct your response to the following address:

PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850.

If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at Elenita.IbarraPratt@fda.hhs.gov.

Sincerely,

/S/

Ann Simoneau, J.D.

Director

Office of Compliance and Enforcement

Center for Tobacco Products

VIA UPS

cc:

GoDaddy.com, Inc.

14455 North Hayden Rd., Suite 219
Scottsdale, AZ 85260

ReposterÃa Aymat, Inc. 9/30/11


Department of Health and Human Services	Public Health Service Food and Drug Administration
	466 Fernandez Juncos Avenue San Juan, Puerto Rico, 00901 Compliance Branch Telephone: 787-474-9500 FAX: 787-729-6658

September 30, 2011

WARNING LETTER
11-SJN-WL-16

OVERNIGHT MAIL
Returned Receipt Requested

Mrs. Olga Aymat Chacon, President
Repostería Aymat, Inc.
225 Calle Eleonor Roosevelt
San Juan, PR 00918-3010

Dear Mrs. Aymat:

The United States Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 225 Calle Eleanor Roosevelt, San Juan PR, from May 4 – 5 and 12, 2011. This inspection found that you have serious violations of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Food (CGMP) regulations, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the products prepared or stored at your facility to be 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)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health.

In addition, FDA collected product labels and samples of your pastry products during the inspection of your facility. Based on our review of the labels, we have determined that your Donas Glaceadas Aymat products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343] and its implementing regulations in Title 21, Code of Federal Regulations (CFR), Part 101 [21 CFR Part 101]. You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov.

Your significant violations are as follow:

1. Your firm failed to maintain equipment, utensils, in an acceptable condition through appropriate cleaning and sanitizing in accordance with 21 CFR 110.80(b)(1). For example:

• On 05/05/2011, our Investigators observed rust on the impeller of your industrial mixer used to prepare donut glaze. The Investigators also determined that you do neither use cleaning nor sanitation agents to clean the mixer due to its geometric configuration. The Investigators further determined that you only use hot water to remove food residues from the mixer at the conclusion of your daily manufacturing operations.

• On 05/05/2011, our Investigators observed that bins used during manufacturing operations were not cleaned showing old food residues.

• Trays utilized inside the proofing cabinet showed residues of dark grease, dirt and encrusted food. The Investigators observed that four of these trays were hanging from a dirty shelf on the wall of your production area. The Investigators also determined that trays are never dismantled for cleaning and they are only wiped with a wet rag from time to time because they do not need to be cleaned due to the high temperatures inside the proofer.

• On 05/05/2011, our Investigators observed that two cooling fans used to cool the fried and glazed donuts located throughout the conveyor line were covered with dust. These fans were blowing air directly over unprotected finished donuts.

2. Your firm’s employee failed to wash hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and any other time when the hands may have become soiled or contaminated in accordance with 21 CFR 110.10(b)(3). Specifically, an employee touched food dough with his bare hands without washing and or sanitizing first. This same employee was observed to have touched tools, utensils and water used to moisten equipment parts prior to touching the food dough.

3. Your firm’s employee failed to maintain gloves in food handling in an intact, clean and sanitary condition in accordance with 21 CFR 110.10(b)(5). Specifically, the Investigators observed that one of your employees touched his forehead, clothes, and different equipment parts with his gloves on before handling finished product. This particular employee did not change, wash or sanitize his gloves prior to touching the previously mentioned items.

4. Your firm’s employees failed to wear beard covers where appropriate in accordance with 21 CFR 110.10(b)(6). For instance, on 05/05/2011, the Investigators observed that three employees working during the donuts packaging operations failed to cover their mustaches and beard.

Misbranding

5. Your Donas Glaceadas Aymat brand product (glazed donuts) is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the label for this product fails to declare the known major food allergens, soy and wheat, as specified by the Act.

Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines as “major food allergens” milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:

• The word “Contains,” followed by the name of the food source from which the major food allergen is derived, printed immediately after or adjacent to the list of ingredient, section 403 (w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or

• The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g. “(wheat)”), except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act, [21 U.S.C. 343(w)(1)(B)].

Your Donas Glaceadas Aymat brand product (glazed donuts) product formulation reveals that margarine and High Gluten Spring Wheat Flour are used in the manufacturing process. Margarine contains soy lecithin as a sub-ingredient and the flour is prepared by grinding and bolting cleaned wheat. Soy and wheat are major food allergens; however your finished product label fails to declare the presence of soy and wheat.

Further guidance and information on food allergens can be accessed on FDA’s website at:
http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.

6. Your Donas Glaceadas Aymat brand product (glazed donuts) is misbranded within the meaning of section 403(i)(2) [21 U.S.C. § 343(i)(2)] of the Act in that your label fails to declare all of the ingredients used by your firm in the production of these donuts in accordance with 21 CFR 101.4. For example:

• The affidavit collected during the inspection states that dough softener, yeast, and baking powder are used in the manufacture of your donuts, however based on the ingredient statement the dough softener, yeast, and baking powder are not declared on your product label in accordance with 21 CFR 101.4(a)(1).

• Your product label declares “manteca vegetal” (vegetable fat or lard) however you fail to identify the individual fat and/or oil ingredient by its specific common or usual name (e.g., soybean and cottonseed oil) in accordance with 21 CFR 101.4(b)(14).

The requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient. Under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

• We also note that your donut products declare “Harina Enriquecida” (enriched flour) which makes reference to the High Gluten Spring Wheat Flour. Enriched flour is a food for which a standard of identity has been established in Section 21 CFR 137.165 and contains wheat flour, niacin, iron, thiamin mononitrate, riboflavin, and folic acid. These components are not listed on the ingredient statement of your Donas Glaceadas Aymat brand product. If your glazed donut products contain enriched flour, you must declare all of the ingredients in the enriched flour.

7. Your Donas Glaceadas Aymat brand product (glazed donuts) is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because the label fails to bear nutrition labeling information in accordance with 21 CFR 101.9. Specifically,

• Your Donas Glaceadas Aymat brand product label fails to bear a statement of the number of grams of Trans Fat in accordance with 21 CFR 101.9(c)(2)(ii);

• Your Donas Glaceadas Aymat brand product label fails to declare the % Daily Values in the Nutrition Facts box as required by 21CFR 101.9(d)(7)(i) and (ii);

• Your Nutrition Facts panel on the 16oz Donas Glaceadas Aymat brand product appears to be on the bottom of the box, which is not acceptable; rather it must be located on the information panel in accordance with [21 CFR 101.2(d)(1)].

Your firm may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review the nutrition labeling exemptions in 21 CFR 101.9(j)(18), or see :

http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/SmallBusinessNutritionLabelingExemption/default.htm, for information on filing for an annual exemption. The application may be submitted online at:

https://info1.cfsan.fda.gov/nle/client/login.cfm.

This letter is not meant to be an all-inclusive list of the violations at your manufacturing facility or in your product labeling. It is your responsibility to ensure that your products comply with all of the laws and regulations enforced by FDA, including the CGMP regulations (21 CFR Part 110) and the Food Labeling regulations (21 CFR Part 101).

You should take prompt action to correct the violations described above and prevent future recurrence. Failure to correct these violations may result in further enforcement action being initiated by the FDA without prior notice. For instance, the Act provides for the seizure of violative products, the assessment of civil money penalties, and the injunction of a manufacturer or distributor of violative food products.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. Additionally, your response should include other useful information that would assist us in evaluating your corrections. If you can not complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

FDA acknowledges receipt of your response letter received on June 1, 2011, which identifies the corrective actions you have taken or plan to take in response to the Inspectional Observations reported to you on the form FDA-483 issued on May 12, 2011. Our review finds that most of the proposed and corrective actions taken appear to be adequate. However, because you provided no photographs or other evidence to assist FDA in determining the adequacy your corrections, FDA cannot fully evaluate those corrections based solely on your written response. The corrections will be verified and evaluated during the next inspection of your facility.

Further, FDA still has concerns about your current employee practices. Although your response letter proposed that formal CGMP training will be provided to all of your employees as a preventive action, the letter failed to specify when the training will be delivered.

We also point out, your 16 ounce and 8 ounce donut labels declare information in both Spanish and English, however, the ingredient statement, net weight, and manufacturers address on these labels do not appear in both languages in accordance with 21 CFR 101.15(c).

Please send your written reply to the Food and Drug Administration, attention: Rafael Nevarez, Compliance Officer, 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Nevárez at (787) 474-9545.

Sincerely,

/s/

Maridalia Torres
District Director
San Juan District

GRAND BK CORP. 9/30/11


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

September 30, 2011

WARNING LETTER NYK-2011-38

VIA UNITED PARCEL SERVICE

Brian J. Kwon, President
Grand BK Corp.
47-08 Grand Avenue
Maspeth, New York 11378-3007

Dear Mr. Kwon:

We inspected your seafood processing and importer establishment, located at 47-08 Grand Avenue, Maspeth, New York between August 4 and 15, 2011. 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 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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).

As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. §342(a)(4).

Accordingly, your salted fish products, including but not limited to, pacific saury, croaker, butterfish, Spanish mackerel, beltfish, atka mackerel, and golden pompano 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 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 plan for salted vacuum packed fish lists a critical limit, water phase salt greater than or equal to (b)(4)%, at the brining critical control point that is not adequate to control Clostridium botulinum. We acknowledge that your label states to keep this product frozen, which would control nonproteolytic Clostridium botulinum. However, the product labeling does not include any thawing instructions, which would control the Clostridium botulinum hazard.

2) 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c) (1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP plan for Salted Fish, which includes salted pacific saury does not list the food safety hazard of scombrotoxin formation.

3) You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control

a. Clostridium botulinum when your process for salted croaker, salted butterfish, and salted pacific saury deviated from your critical limit at the brining critical control point. On December 8, 2010, your private lab analysis results for water phase salts for salted croaker (b)(4)(%), salted butterfish (b)(4)(%), and salted pacific saury (b)(4)(%) were below your critical limit for air-packed fish of greater than or equal to (b)(4) % water phase salt. Our inspection reveals you have not taken any corrective action for these products.

b. pathogen growth when your process for salted pacific saury deviated from your critical limit at the packaging / labeling critical control point. Your critical limit for the packaging / labeling critical control point states all products must be labeled (b)(4) During the current inspection, our investigator observed salted pacific saury with out the required labeling statement and you did not take any corrective action.

4) You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the packaging / labeling critical control point to control pathogen growth listed in your HACCP plan for Salted Fish. According to the current inspection this HACCP plan for salted fish includes saury, croaker, Spanish mackerel, beltfish, atka mackerel, and golden pompano that may either be air or vacuum packed.

5) You must 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 the safety of water that comes into contact with food or food contact surfaces, and prevention of cross-contamination from insanitary objects with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by the following observations made by the FDA investigator on August 4, 2011:

a. a high pressure hose without an appropriate backflow prevention device was observed submerged in tank of raw belt fish;

b. cleaned cutting board were stored on an surface that was not cleaned;

c. food was exposed when the floor was being rinsed with a high pressure hose; and

d. condensate from an air conditioning unit was observed falling onto belt fish prior to processing.

6) You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8(a). However, your firm did not verify the adequacy of the critical limit of water phase salt greater than or equal to (b)(4)%, for vacuum packed salted fish at the brining critical control point to control Clostridium botulinum. The verification in your HACCP plan of (b)(4) and the verification in your scheduled process of (b)(4) do not require appropriate water phase salt levels to show the identified hazard is controlled. In addition, the frequency of testing is not adequate. Furthermore, your records reveal you are not following this verification procedure. For example, you have water phase salt testing records for February of 2009 and the next record for this testing was eight month later in October 2009, and the next record after this testing was fourteen months later in December of 2010.

7) You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedures of (b)(4) and your scheduled processes for making a brine solution at brining critical control point to control Clostridium botulinum and pathogen growth listed in your HACCP plan for Salted Fish including salted pacific saury.

8) You must implement an affirmative step designed to ensure that the fish and fishery products that you import are processed in accordance with the requirements of seafood HACCP regulations, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for saury (a.k.a. mackerel pike/ sanma) imported from (b)(4) located in Japan.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.

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 importer verification records, records that document the performance and results of your firm’s affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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 seafood importer establishment operates in compliance with the Act and 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 for your fish or fishery products, including those that you import into the United States.

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,

/S/
Ronald M. Pace
District Director
New York District

cc: Vinny Kim, Sr. Sanitation Manager, H Mart Inc., 300 Chubb Avenue, Lyndhurst, New Jersey 07071

El Chilerito Spice Co. Inc. 9/30/11


Department of Health and Human Services	Public Health Service Food and Drug Administration
	Los Angeles District 19701 Fairchild Irvine, California 92612-2506 Telephone (949) 608-2900 Fax (949) 608-4415

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

September 30, 2011

W/L 58-11

Mr. Jorge Reyes, President
El Chilerito Spice Co. Inc.
1613 Potrero Avenue
South El Monte, CA 91733

Dear Mr. Reyes:

On January 26, 2011 through February 3, 2011, FDA conducted an inspection of your firm concurrently with a USDA-FDA joint investigation. The inspection was initiated as a result of information obtained by USDA investigators at one of your firm’s customers and covered your receiving, storage, labeling and distribution practices. Subsequent analyses of five samples of your Pimienton Chorizero spice product collected from three of your customers during the joint investigation were found to be adulterated within the meaning of section 402(c) [21 U.S.C. § 342 (c)] of the Act because the products bear or contain a color additive which is unsafe within the meaning of section 721(a) and were found to be misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Act in that the labeling did not contain required information.

Your Pimienton Chorizero product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. 342(c)] because it bears or contains color additives which are unsafe within the meaning of section 721(a) of the Act. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with a color additive listing regulation. Specifically, the product contains Cochineal Red A (Ponceau 4R) and Carmoisine, neither of which are listed in FDA regulations.

Your Pimienton Chorizero product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)] because the products bear or contain an artificial flavoring, coloring, or chemical preservative and do not bear labeling stating that fact. In accordance with 21 CFR 101.22(k) the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients.

Your Pimienton Chorizero product is manufactured with Sunset Yellow FCF; however, the product does not bear a label identifying the presence of this color additive. Sunset Yellow FCF is certifiable as FD&C Yellow No. 6. Under 21 CFR 101.22(k)(l ), color additives subject to certification must be declared by the name of the color additive listed in the applicable regulation in part 74 or part 82 of this chapter. The common or usual name may be abbreviated to omit the "FD&C" prefix and the term "No." (e.g., Yellow 6).

Your Pimienton Chorizero product is misbranded under section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product fails to bear the common or usual name of the food in accordance with 21 CFR 101.3.

Your Pimienton Chorizero is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the “Pimienton Chorizero” is fabricated from two or more ingredients, but fails to bear the common or usual name of each ingredient as specified by 21 CFR 101.4.

For ingredients that are themselves composed of two or more ingredients, (e.g., mayonnaise), the requirement to list the component ingredients (or “sub-ingredients”) may be met by either (1) parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or (2) listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient. Under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

Your Pimienton Chorizero product is misbranded under section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)] in that the product fails to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The product is further misbranded under section 403(e)(2) because the product does not declare the net quantity of contents on the unlabeled product in accordance with 21 CFR 101.105.

This letter is not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products comply with the Act and its implementing regulations.

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 or plan to take to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring in the future. 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.

We also note that prior to the investigation that is the main subject of this letter, on June 30, 2010 an FDA Investigator visited your firm and collected shipping documents pertaining to the Chile Guajillo sent to (b)(4). Your firm informed the FDA Investigator that the remaining (b)(4) cartons of the original shipment were being held in your warehouse and would remain quarantined until further advisory from the FDA. On July 2, 2010, we obtained an isolate from the private laboratory that analyzed the Chile Guajillo shipment sent to (b)(4). This isolate was subsequently confirmed by the FDA laboratory to be Salmonella Idikan.

The Chile Guajillo that was returned by (b)(4) was received by your firm on July 12, 2010. Your firm provided a reconditioning proposal on July 15, 2010 to the Los Angeles District Office to have the entire shipment of (b)(4) cartons containing Chile Guajillo peppers treated with (b)(4). You contacted the Los Angeles District Office and informed our Compliance Branch that this shipment was being held intact. After submitting several revised proposals to address deficiencies, your proposal was eventually approved on November 5, 2010.

On November 19, 2010, an FDA Investigator examined (b)(4) cartons of chili peppers at the reconditioning facility which were identified with the original (b)(4) tags as “Guajillo (b)(4)”. However, the cartons did not match the original cartons examined by the FDA Investigator at (b)(4) and they were not marked as “Chile Guajillo”.

On November 23, 2010, an FDA Investigator visited your firm to investigate the missing product. Your firm was not able to account for the missing (b)(4) cartons of Salmonella contaminated Chile Guajillo peppers and later determined that the product had been commingled and shipped to customers. Your firm provided a distribution list accounting for all Chile Guajillo distributed by your firm after receipt of the Salmonella contaminated Chile Guajillo from (b)(4). On September 15, 2010, your firm shipped (b)(4) of Chile Guajillo to your customer (b)(4)) located in (b)(4). On December 10, 2010 your firm initiated a voluntary recall of all Chile Guajillo from (b)(4) distributed by your firm from July 8 through November 24, 2010.

A follow-up investigation was conducted at your firm on December 16, 2010. This investigation revealed that you misrepresented the (b)(4) cartons sent for reconditioning at the (b)(4) facility on November 19, 2010 as the Chile Guajillo peppers returned by (b)(4).

In your response to this warning letter, please include documentation of the corrective actions you have taken as well as steps you have taken to improve your recall system, such as warehousing practices including, but not limited to, product quarantine, as well as corrections to your labeling procedures. In addition, please inform us of the steps you have taken to verify that products you receive from your suppliers are in compliance with the Act. Again, it is your responsibility to ensure that all of your products comply with the Act and its implementing regulations. The introduction or delivery for introduction into interstate commerce of any food that is adulterated or misbranded is a prohibited act under section 301(a) of the Act. Violations of Section 301 of the Act can result in civil and/or criminal penalties. Failure to prevent future violations may result in regulatory action without further notice such as seizure, injunction, detention without physical examination of shipments, debarment, and/or criminal prosecution.

Please send your reply to the Food and Drug Administration, Attention:

Blake Bevill
Compliance Director
Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506

If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.

Sincerely,

/s/

Alonza E. Cruse
District Director
Los Angeles District

Thursday, September 29, 2011

Donuts Deluxe 9/29/11


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) 334-4100 FAX: (612) 334-4142

September 29, 2011

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 11 – 58

Huy Q. Ha
Owner
Donuts Deluxe
1640 County Road E
Vadnais Heights, Minnesota 55110

Dear Mr. Ha:

An investigator from the Minneapolis District Office of the Food and Drug Administration (FDA) inspected your processing facility located at 1640 County Road E, Vadnais Heights, Minnesota, on May 23-26, 2011. Our inspection found significant deviations from the food labeling regulations, Title 21, Code of Federal Regulations (21 CFR), Part 101. These violations cause the “French Bread” distributed by your firm to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C § 343, in that it is not labeled with the mandatory information required by the Act. You may find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.

Your significant violations include:

1. Your French bread product is misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the label fails to declare the major food allergen as specified by the Act.

Section 201(qq) of the Act, 21 U.S.C. 321(qq), defines as “major food allergens” milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:

• The word “Contains,” followed by the name of the food source from which the major food allergen is derived, printed immediately after or adjacent to the list of ingredient, section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A); or

• The common or usual name of the major food allergen in the list of ingredients followed by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list (unless the name of the food source is listed but not as a part of the name of an ingredient which is not required to be declared as a major food allergen), section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B).

Your French bread product is manufactured using “flour” and flour is the food prepared by grinding and bolting cleaned wheat, other than durum wheat and red durum wheat. Wheat is a major food allergen required to be declared on the product label. Further guidance and information on food allergens can be accessed on FDA’s website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.

2. Your French bread product is misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2), because ingredients required to be declared on the label or labeling of a food, including foods that comply with standards of identity, are not declared on your label, as required by 21 CFR 101.4(a)(1). In particular, the French bread label declares “flour;” however, based on information provided during the inspection, the flour is enriched bromated flour which contains sub-ingredients that are not declared on the finished product label in accordance with 21 CFR 101.4(b)(2).

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 and the food labeling regulations (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin
your firm from operating.

Further, this letter acknowledges receipt of your letter of June 10, 2011, responding to the Form FDA-483, Inspectional Observations, issued on June 26, 2011, as a result of our inspection of your production facility. Your response has been made a part of the Minneapolis District’s permanent file for your firm. The effectiveness of the corrections you have made or will be implementing will be evaluated during the next inspection. We note that your response to item 1 addresses only the placement of the frozen eggs container on the floor of the processing room. This item should address both the placement on the floor and the thawing of product at room temperature which could allow pathogenic organisms the opportunity to grow. All frozen products should be thawed under conditions of refrigeration.

We provide the following comments:

• During our label review we noted that your French bread product does not contain the ZIP code on the label in accordance with 21 CFR 101.5(d);

• Your French bread label declares “yeast” which contains the sub-ingredients sorbitan monostearate and ascorbic acid. However, the ingredients sorbitan monostearate and ascorbic acid are not declared on the label for your French Bread as required by 21 CFR 101.4(b)(2).

Please 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 verification records and revised labeling, 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.

Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letterhead.

Sincerely,

/s/

Gerald J. Berg
Director
Minneapolis District

Wednesday, September 28, 2011

Lebanese Arak Corp 9/28/11


Department of Health and Human Services	Public Health Service Food and Drug Administration
	Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

September 22, 2011 WL 56-11

Garo Kurkjian, President

Lebanese Arak Corp

724 Thompson Ave

Glendale, CA 91201

Dear Mr. Kurkjian:

The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, Lebanese Arak Corp located at 724 Thompson Ave, Glendale, CA 91201, on 04/25/11-4/29/11. The inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation [21, Code of Federal Regulations (CFR) Part 120], and the Current Good Manufacturing Practice regulation for food, [21 CFR Part 110]. In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with 21 CFR Part 120, or otherwise operate in accordance with the requirements of this part, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Food Drug and Cosmetic Act [21 U.S.C. § 342(a)(4)]. Accordingly, your lemon and lime juice products are adulterated in that they have been prepared packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

Also, as further discussed below, several of your products are misbranded within the meaning of Section 403 of the Act.

You may find the Act, FDA’s labeling and juice HACCP regulations, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.

The significant violations documented during the inspection include the following:

You must include in your hazard analysis and HACCP plan control measures that will consistently produce, at a minimum a 5 log reduction of the pertinent microorganism for at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, as required by 21 CFR 120.24(a). However, your critical limit of “pH less than 4.6” at the blending critical control point (CCP) in your Juice Products HACCP plan does not ensure control of pathogenic microorganisms, including Listeria monocytogenes, in your 100% lemon and lime juices.

We received your written response dated May 10, 2011. In your response, you indicate that you consulted with an industry expert and determined a pH level of 4.6 is acceptable. Your response is inadequate because you do not have scientific data or evidence that the current critical limit will consistently produce a 5 log reduction of the pertinent microorganism. We reviewed the validation study performed by (b)(4). The study used USP 24 <51> - Antimicrobial Effectiveness Test. USP 24 <51> is an effectiveness test used for pharmaceutical products and is not intended to validate a five log reduction process. In addition, the study data provided during the inspection does not identify the test parameters such as sample pH, total acidity, preservative concentrations, time or temperature that may be critical factors of the process. The conclusion stated by (b)(4) is that “*** A preservative is considered effective against bacteria if at least a 1 log reduction of bacteria occurs from the initial count at 14 days and there is no increase from 14 days to 28 days. Preservative is effective against all test organisms based on USP <51> procedure.” Our review finds that the study does not demonstrate a 5 log reduction of bacterial pathogens. The study also did not cover Listeria monocytogenes, the pertinent microorganism in reconstituted juices.

Your HACCP plan must, at a minimum, list the critical control points for each identified food hazard that is reasonably likely to occur, as required by 21 CFR 120.8(b)(2). However, your HACCP plan for consumer labeled 100% lemon and lime juices does not list a critical control point for controlling the food hazard of added sulfites. Your firm identified sulfites as a significant hazard reasonably likely to occur but did not address the lack of a critical control point in your HACCP plan, specifically at the labeling step, to control the hazard of added sulfites.

In you response you state “***we have a specific area that is designated in our document to control this allergen in our blending process.” Your response is inadequate because it does not address the lack of a CCP in your HACCP plan at the labeling step to control the hazard of added sulfites.

3. You must have and implement a sanitation standard operating procedure that addresses sanitation conditions and practices before, during, and after processing, as required by 21 CFR 120.6(a), and you must adequately monitor conditions and practices during processing with sufficient frequency to ensure conformance with those conditions, as well as the current good manufacturing practice requirements in 21 CFR Part 110, as required by 21 CFR 120.6(b). However, your firm did not the monitor condition and cleanliness of food contact surfaces; prevention of cross contamination from insanitary objects to food; and labeling, storage and use of toxic compounds, with sufficient frequency as evidenced by the following observed at your facility on 04/27-28/11:

(a) Condition and cleanliness of food contact surfaces [21 CFR 120.6(a)(2)]

Water supply hoses and pump connection hoses used in juice production were observed on the production room floor and/or held in unclean buckets were used to produce lemon juice lot #4203 without first being cleaned and sanitized.
The utensils and buckets used in the manufacture of your 100% juice products are not cleaned and sanitized prior to use. These items are only rinsed with water.
A bucket used to transfer sodium benzoate and potassium sorbate was stored under a work station on 4/27/11. The container contained a visible build-up of white, powdery residue. The container was used to measure raw materials and was returned to the workstation shelf without cleaning. The container was used again during manufacture of 100% lemon juice on 4/28/11.
A glass jar was used to transfer lemon oil to the blending tank during production of lemon blend on 4/27/11. The container was placed on a shelf without cleaning and covered with a wooden board. The container was still on the shelf as such on 4/28/11.

(b) Prevention of cross contamination from insanitary objects [21 CFR 120.6(a)(3)]

Buckets placed in standing water on the floor of your production facility were used to transfer juice from the filler back into the blending tank. Drops of water from the side of the bucket were observed falling into the tank during juice production.
Two employees were observed rinsing their hands without use of soap in the three-compartment sink where utensils are also rinsed. The employee’s hands were observed in contact with water that was added to juice concentrate as well as in rinsing pitchers and buckets used to transfer juice product to and from the blending tank.
Employees were manufacturing juice products wearing street clothes without protective outer garments.
Employees with uncovered facial hair were observed working directly over juice concentrate and in-process juice in the blending tank.
Employees with hairy arms were observed not wearing gloves or arm covers during processing on 4/27/11. Employees were also observed with unprotected hands/arms during transfer of juice to the blending tank and during filling of bottles that had not been completely filled by the filler on 4/28/11.

On 4/27/11, the intake vent of the table motor was observed visibly soiled with an accumulation of dust. The vent cover was directly over open bottles on their way to the filler. The motor housing was observed to vibrate while the open bottles were passing underneath.

(d) Labeling, storage and use of toxic compounds [21 CFR 120.6(a)(6)]

On 4/27/11 and 4/28/11, the concentration of chlorine based sanitizer effluent from the filling machine was measured at above 200 ppm.

Your response is inadequate because it did not address many of the sanitation deficiencies. Your response indicated that you have taken the actions listed below; however, this is inadequate because further documentation is needed:

You have placed an order for hoses that will dangle from the ceiling and not touch the ground. Your response is inadequate because you have not provided receipts or evidence of the purchase of the new hoses.
You have implemented outer garments that are to be worn by anyone working in the facility. Your response is inadequate because you have not provided details or documentation of this correction.
You placed signs in various locations and in the bathrooms directing employees to wash their hands. Your response is inadequate because you have not provided documentation of retraining employees on hand washing or documentation of enhanced monitoring of employees to ensure that they are washing their hands as necessary.
You will be implementing a new Clean in Place (CIP) system, revising your cleaning and sanitizing procedures, and changing the chemicals used. You also provided a blank record titled “SANITATION PROCESS” in your response. However, you have not provided evidence of correction such as current sanitation monitoring records indicating proper sanitizer concentrations.

Misbranding

1. Your “Sadaf Natural Lemon Juice” and “Golchin Lime Juice” products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)], which states that a food shall be deemed to be misbranded if its labeling is false or misleading in any particular.

Your “Sadaf Natural Lemon Juice” product is misbranded because the label uses the term “natural” in a manner that is false and misleading FDA considers use of the term “natural” on a food label to be truthful and non-misleading only when nothing artificial or synthetic has been included in, or has been added to, a food that would not normally be expected to be there [58 FR 2302, 2407, January 6, 1993; see 21 CFR 101.22(a)]. Because your product contains sodium benzoate and sodium bisulfite, which are chemical preservatives, the use of the claim “natural” on the product label is false and misleading.

2. Your Sadaf Apple Cider Vinegar is misbranded within the meaning of 403(q) of the Act [21 CFR U.S.C. 343(q)] in that your product’s nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example:

The serving size declaration is incorrect. Your product would be considered a major condiment. Based on 21 CFR 101.12, the proper serving size declaration would be, “1 tbsp (__g); 1 tbsp (15mL).
The Trans Fat content is not declared as required by 21 CFR 101.9(c)(2)(ii).

The above violations are not intended to be an all-inclusive list of violations. It is your responsibility to ensure that all of your products are in compliance with the Act and FDA’s regulations. 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 without further notice, such as seizure and/or injunction.

We also note the following comments about your product labels:

Your “Sadaf Natural Lemon Juice” and “Golchin Lime Juice” fail to declare the term “From Concentrate” in type size no less that one-half the height of the letters in the name of the juice, as required by 21 CFR 102.33(g)(1).
Your “Golchin Lime Juice” fails to declare the word “Blend” in the same type size as the rest of the statement of identity [21 CFR 101.3(d)].
Your Golchin Lime Juice label contains foreign characters. In accordance with 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must also appear in the foreign language.

You should 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 revised HACCP plans, revised sanitation standard operating procedures, recent monitoring records, training records, and revised labeling. 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.

Please send your reply to the Food and Drug Administration, Attention:

Blake Bevill

Director Compliance Branch

Los Angeles District

19701 Fairchild

Irvine, CA, 92612-2506

If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at 858-550-3850 x106.

Sincerely,

/S/

Alonza E. Cruse

District Director

Los Angeles District

Cc:

Ingeborg Small, Branch Chief

California Department of Public Health

Food and Drug Branch

1500 Capitol Avenue, MS-7602

P.O. box 997435

Sacramento, CA 95899-7435

Tuesday, September 27, 2011

Middlesboro Appalachian Regional Hospital 9/27/11

Department of Health and Human Services

Public Health Service
Food and Drug Administration

CINCINNATI DISTRICT OFFICE

6751 Steger Drive

Cincinnati, OH 45237-3097

513-679-2700; FAX 513-679-2772

September 27, 2011

WARNING LETTER CIN-11-224035-27

MAILED VIA UPS

Michael Slusher
Chief Executive Officer
Middlesboro Appalachian Regional Hospital
3600 W. Cumberland Ave.
Middlesboro, KY 40965

Dear Mr. Slusher:

RE: Inspection ID 2022180017

On August 18,2011, a representative of the Commonwealth of Kentucky, acting on behalf of the Food and Drug Administration (FDA) inspected your facility. This inspection revealed a serious problem involving the conduct of mammography at your facility. Under the Mammography Quality Standards Act of 1992 ("MQSA") which is codified in Section 263b of Title 42 of the United States Code (USC), your facility must meet specific requirements to practice mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography.

The inspection revealed violations of the MQSA at your facility. These violations were noted on the MQSA Facility Inspection Report and the document "Important Information about Your MQSA Inspection" that the inspector mailed to Ms. Kathy Miracle, Director of Radiology of your facility on August 19, 2011. The violations are again identified below.

1. Level 2 (Repeat): Failed to produce documents verifying that two (2) of the radiologic technologists met the continuing experience requirement of having performed 200 mammography examinations in 24 months. ((b)(4) and (b)(4)) See 21 CFR 900.12(a)(2)(iv)

2. Level 2: The mammography equipment evaluation (by a medical physicist) for laser printer (b)(4) in the mammography room) was not done. See 21 CFR 900.12(e)(10)

On August 31, 2011, we received your facility response to the MQSA Facility Inspection Report. Your facility's response was inadequate in that Ms. Miracle responded with no plan of action of permanent correction for assurances that these non compliance issues do not recur.

Also, during the following previous annual MQSA inspections, your facility was cited for the same noncompliance issue as mentioned in above item #1:

1. August 26, 2010, along with one other Level 2 citation: "Failed to produce documents verifying that the radiological technologist (b)(4) met the continuing experience requirements of having performed 200 mammography examinations in 24 months. See 21 CFR 900.12(a)(2)(iv)

2. September 18, 2008, "Failed to produce documents verifying that the radiological technologist (b)(4) met the continuing experience requirements of having performed 200 mammography examinations in 24 months. See 21 CFR 900.12(a)(2)(iv)

3. November 13, 2007, along with one of three Level 2 citations: "Failed to produce documents verifying that the radiological technologist (b)(4) met the continuing experience requirements of having performed 200 mammography examinations in 24 months. See CFR 900.12(a)(2)(iv)

4. September 24, 2003, "Failed to produce documents verifying that the radiologic technologist (b)(4) met the continuing experience requirement of having performed 200 mammography examinations in 24 months. See 21 CFR 900.12(a)(2)(iv)

5. September 11, 2001, along with one of three Level 2 citations: "Failed to produce documents verifying that the radiological technologist (b)(4) met the continuing experience requirements of having performed 200 mammography examinations in 24 months. See 21 CFR 900.12(a)(2)(iv)

Because the continued failure to resolve these violations may be indicative of serious underlying problems that could compromise the quality of mammography at your facility, FDA may take additional actions, including, but not limited to, the following:

requiring your facility to undergo an Additional Mammography Review

placing your facility under a Directed Plan of Correction

charging your facility for the cost of on-site monitoring

seeking civil money penalties up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with, MQSA standards

seeking to suspend or revoke your facility's FDA certificate

see 42 USC 263b(h)-(j) and 21 CFR 900.12(j).

FDA may need to perform a fee based Compliance Follow-up Inspection to determine that each problem at your facility has been corrected.

You should respond in writing to FDA within fifteen (15) working days from the date you received this letter. Your response should address the findings listed above and include:

1. the specific steps you have taken, or will take, to correct all of the violations noted in this letter, including projected timeframes for implementing those steps;

2. the specific steps you have taken, or will take, to prevent the recurrence of similar violations, including projected timeframes for implementing those steps;

3. sample records that demonstrate proper record keeping procedures;

Please submit your response to this letter to:

Mr. R. Terry Bolen
MQSA Compliance Officer
Food and Drug Administration
36 East Sixth Street, Suite 1910
Cincinnati, OH 45202
513-246-4134
FAX: 513-381-0219

Please send a copy of your response to:

Robert Gresham
Supervisor
Commonwealth of Kentucky
Cabinet for Health and Family Services
Radiation Producing Machine Program
275 East Main St.
Frankfort, KY 40621-0001

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspections of your facility and does not necessarily address other obligations you have under the law. You may obtain general information about all of FDA's requirements for mammography facilities by contacting the Mammography Quality Assurance Program, Food and Drug Administration, P.O. Box 6057, Columbia, MD 21045-6057 (1-800-838-7715) or through the Internet at http://www.fda.gov/cdrh/mammography/index.html.

If you have additional or more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact R. Terry Bolen at 513-246-4134.

Sincerely yours,
/S/

Cheryl A. Bigham

Acting District Director

Cantor & Nissel Ltd.


Department of Health and Human Services	Public Health Service Food and Drug Administration

September 27, 2011

WARNING LETTER

VIA UNITED PARCEL SERVICE

David Cantor

Chairman

Cantor & Nissel, Ltd.

Market Place

Brackley, Northamptonshire,

United Kingdom

Dear Mr. Cantor:

During an inspection of your firm located in Brackley, Northamptonshire, United Kingdom, on April 26 through April 28, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Daily Wear Soft Contact Lenses. 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 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.

This inspection revealed that these 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. We received a response from your firm dated May 16, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to maintain adequate complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

The procedures shall ensure that:

a. All complaints are processed in a uniform and timely manner;

b. Oral complaints are documented upon receipt; and

c. Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under Part 803, Medical Device Reporting.

For example, your firm has no written complaint handling procedures. Instead, complaints are recorded on the corrective and preventive action (CAPA) form.

Your firm’s response did not address this observation because it was not listed on the FDA 483.

2. Failure to establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individuals performing the maintenance activities, shall be documented, as required by 21 CFR 820.70(g)(1).

For example, your firm’s personnel stated (b)(4)

We reviewed your firm’s response and conclude that it is adequate.

3. Failure to establish and maintain adequate procedures for verifying or validating corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).

(b)(4)

We reviewed your firm’s response and conclude that it is not adequate. Section 6.7 of your firm’s Corrective and Preventive Action procedure (b)(4) states that a follow–up verification will be done to assess and determine the effectiveness or any adverse effect to the final product. However, (b)(4) does not address validation of corrective and preventive actions.

Our inspection also revealed that your firm’s ChromaGen V2.0 Haploscopic System & Color Discrimination Enhancement Soft Lens devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR). Significant violations include, but are not limited to, the following:

Failure to have an adequate written MDR procedure establishing internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR § 803.17(a)(1).

A review of your firm’s MDR procedure identified the following deficiencies

Your firm’s procedure does not define “cause or contributed” and “serious injury,” as stated in 21 CFR 803.3. The exclusion of these terms in the procedure may lead the firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
Your firm’s procedure does not include a process for identifying and evaluating events occurring outside the U.S. as potentially reportable to FDA, as required by 21 CFR 803.50 and 803.53. If an event occurs in a foreign country, it may be reportable under the MDR regulation if the event involves a device that has been cleared or approved in the U.S. and is also lawfully marketed in a foreign country. Devices may be manufactured to slightly modified specifications to meet standards in different countries. If these changes do not substantially alter the performance of the device, then any adverse event that are MDRâ€‘reportable events relating to such modified devices should be reported under the MDR regulation. By not considering events that occur outside of the U.S., potentially reportable MDRs may not be identified and evaluated for MDR decision making and submission to FDA as required by 21 CFR 803.50 and 803.53.
As initial distributors, (b)(4) only need to keep MDR files as required by 21 CFR 803.18(d). If the two firms act as initial importers for your firm, then they must comply with the requirements in 21 CFR 803.17, 803.18, 803.40, and 803.42. However, your firm, (b)(4) may request an exemption under 21 CFR 803.19 that will allow the submission of one MDR for events in which your firm, (b)(4) have an obligation to submit a report to FDA.
Under 6.3, of your procedures, Criteria for Reporting Within the US, your firm’s procedure states, (b)(4) This statement may lead to incorrect MDR decisions. As stated in 21 CFR 803.50(b)(3), the manufacturer is responsible for conducting an investigation of an event and evaluating its cause to determine whether the complaint should be reported to FDA.
Your firm should make an MDR decision based on information obtained during the course of its investigation and evaluation of the cause of the event.

We have the following recommendation:

The Medical Device Reporting requirement for Baseline Reporting was repealed under a rule that became effective on October 27, 2008. Therefore, the reference to Baseline Reporting in Section 6.6, Information to be reported for incidents occurring within the USA, can be removed from your firm’s procedure.

U.S. federal agencies may be advised of the issuance of 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review.

Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #207433 when replying. If you have any questions about the contents of this letter, please contact: Mr. Ronald L. Swann at (301) 796-5770 or (301) 847-8137.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.

Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.

Sincerely yours,

/S/

Steven D. Silverman

Director

Office of Compliance

Center for Devices and

Radiological Health

Monday, September 26, 2011

Aesculap AG 9/26/11


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

SEP 26, 2011

WARNING LETTER

VIA UNITED PARCEL SERVICE

Mr. Konrad Kobel

Vice President for Quality Management/Regulatory Affairs

Aesculap AG

Am-Aesculap Platz

Tuttlingen, Germany 78532

Dear Mr. Kobel:

During an inspection of your firm located in Tuttlingen, Germany on May 16, 2011, through May 19, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Craniofix, Yasargil Titanium Alloy Aneurysm Clip, S4 Cervical Occipital Plate Spinal System, and Vega Knee System. 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 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.

Our inspection revealed that your Yasargil Titanium Alloy Aneurysm Clips are misbranded under section 502(t)(2) of the Act 21 USC 352 (t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by under section 519 of the Act, 21 USC 360i, and 21 CFR Part 803 – Medical Device Reporting.

We received a response from you dated June 1, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR Part 803.17.

For example: Your firm’s procedure does not include the requirements for submission of MDRs to FDA. Your firm’s procedure, (b)(4) as written, does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, a standardized review process or procedure for determining when an event meets the criteria for reporting, timely transmission of complete medical device reports, and documentation and recordkeeping requirements, as required by 21 CFR Part 803.17.

We reviewed your firm’s response dated June 1, 2011, and conclude that it is not adequate. Although you provided an English translation of your firm’s procedure, (b)(4) it does not meet the requirements of 21 CFR Part 803.17 as stated above.

Federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the awarding of contracts.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter. Please provide a translation of documentation not in English to facilitate our review.

In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820.

We received responses from you dated June 1, 15, 17, and 30, 2011, concerning our investigator’s observations noted on the FDA 483 that was issued to your firm. These nonconformities include, but are not limited to, the following:

Failure to adequately confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f). (b)(4)

The adequacy of your firm’s response dated June 1, 2011, cannot be determined at this time because your firm did not include objective evidence that the (b)(4) that would provide objective evidence that these procedures are in place and being utilized, were not included for review.

Complaints involving the possible failure of the device to meet any of its specifications have not been adequately investigated as required by 21 CFR 820.198(c). For example: The firm received five complaints (400060307, 400079122, 400079146, 400088744, and 400090631) that described the detachment of the top half of Craniofix (Material numbers FF90T, FF491T, and FF92T) device after the pin was cut. Complaint investigation records indicate the failure may be associated with an angled cut of the pin. It does not appear that an investigation was conducted.

The adequacy of your firm’s response dated June 15, 2011, cannot be determined at this time. Your firm’s response did not include objective evidence (b)(4)

The adequacy of your firm’s response dated June 30, 2011, cannot be determined at this time. Your firm’s response did not include objective evidence (b)(4)

Failure to establish and maintain adequate procedures to control environmental conditions where they could reasonably be expected to have an adverse effect on product quality have not been established and maintained, as required by 21 CFR 820.70(c). For example: (b)(4)

The adequacy of your firm’s response dated June 1, 2011, cannot be determined at this time. Your firm’s response does not indicate that the employees that utilize (b)(4) were trained on the new procedure. Also it is not clear if there was training conducted (b)(4) for the measurement of the differential pressure using the newly installed pressure hoses.

Your firm’s response to this letter should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to the Unique Identification Number 205233 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter at (301) 796-5587 or fax at (301) 847-8139.

Sincerely yours,

/S/

Steven D. Silverman

Director

Office of Compliance

Center for Devices and Radiological Health

Friday, September 23, 2011

X-Ray Support, Inc. 9/23/11


Department of Health and Human Services	Public Health Service Food and Drug Administration
	Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996

September 23, 2011

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply please refer to Warning Letter SEA 11-24

James S. Jacobson
President and Owner
X-Ray Support, Inc.
3020 N. Sullivan Rd., Suite D
Spokane Valley, Washington 99216

WARNING LETTER

Dear Mr. Jacobson:

During an inspection of your firm located in Spokane Valley, Washingtonon May 20, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Dental X-Ray Automatic Film Processors. 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 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.

This inspection revealed that these 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received an email response from you dated May 24, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm. You sent an email to the district stating that the firm would no longer build the ImageMax and requested that the firm be “removed from” the FDA “list”. Therefore, your firm has not formally responded to each of the FDA 483 items. Additionally, a review of the firm’s website on June 14, 2011, and an updated review of the website, http://www.imagemax.us/, on September 7, 2011, demonstrated that your device was still available for sale. Since your firm is continuing to manufacture and distribute the device, your firm is subject to the requirements of the Quality System regulation as set forth in 21 CFR 820. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). For example, your firm has not established procedures for implementing corrective and preventive actions.

2. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, your firm has not established procedures for design control activities.

3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, your firm has not established procedures for purchasing controls activities.

4. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. For example, your firm has not established procedures to control all documents.

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. For example, your firm has not established procedures for conducting quality audits.

6. Failure to maintain a quality system record (QSR), as required by 21 CFR 820.186. For example, your firm has not established a quality system record.

Upon request by the investigator for the above referenced procedures, you indicated the requested procedures were located in your head.

Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. 360(p))] during the period beginning October 1^st and ending December 31^st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal years 2008, 2009, 2010, and 2011.

Therefore all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(o)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).

Your firm 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 the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of 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 violations 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.

Your response should be sent to the US Food and Drug Administration, Attention: Brenda L. Reihing, Compliance Officer, 22201 23^rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about the content of this letter please contact Brenda L. Reihing at (425) 483-4899.

Sincerely yours,

/S/

Charles M. Breen
District Director

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