Van Es Dairy 3/25/11

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

March 25, 2011

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 11-08

Dale Van Es, Owner
Van Es Dairy
8222 Desert Drive
Marsing, Idaho 83639-8264

WARNING LETTER

Dear Mr. Van Es:

On December 8 and 9, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8222 Desert Drive, Marsing, Idaho. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C 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 FD&C 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C 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, 2010, you sold a dairy cow, identified with back tag (b)(4) and ear tag (b)(4), for slaughter as food. On or about June 18, 2010, (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 flunixin in the liver tissue at 0.662 parts per million (ppm). FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver of cattle as codified in Title 21, Code of Federal Regulations, Section 556.286 (21 C.F.R. 556.286). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C 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 FD&C Act, 21 U.S.C. § 342(a)(4).

We also found that you adulterated sulfadimethoxine and flunixin meglumine. Specifically, our investigation revealed that you did not use Albon (sulfadimethoxine) Boluses, NADA 031-715, and Prevail (flunixin meglumine) Injectable, ANADA 200-308, as directed by their approved labeling.  Use of these drugs in this manner is an extralabel use, 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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 Albon (sulfadimethoxine) Boluses, NADA 031-715, to your dairy cows without following the dose as indicated in its approved labeling. Albon (sulfadimethoxine) Boluses, NADA 031-715, is prohibited from extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9). Because your extralabel 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 FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).

In addition, our investigation found that you administered Prevail (flunixin meglumine) Injectable, ANADA 200-308, to your dairy cows without following the dose and duration of treatment as indicated in its approved labeling. Your extralabel use of Prevail (flunixin meglumine) Injectable, ANADA 200-308, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extralabel 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 FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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 Lisa M. Althar, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about this letter, please contact Compliance Officer Lisa M. Althar at (425) 483-4940.

Sincerely,

/s/

Charles M. Breen
District Director

 

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True World Food Boston, LLC 3/25/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New England District One Montvale Avenue Stoneham, Massachusetts 02180 (781) 587-7500 FAX: (781) 587-7556

NWE-14-11W

VIA UNITED PARCEL SERVICE
OVERNIGHT DELIVERY

March 25, 2011

Mr. Hitoshi Okano
Central Manager
True World Food Boston, LLC
22 Foodmart Road
Boston, MA 02118-2802

Dear Mr. Okano

We inspected your seafood processing facility, located at 22 Foodmart Road on October 4, 5, 13, and 27, 2010. 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 & 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 raw refrigerated fluke; Nigiri; and sushi 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 are 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 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). However, your firm’s HACCP Plan # 6 – Primary Process for Fresh Ocean Harvested Fish for raw refrigerated fluke does not list the food safety hazard of parasites.

We are in receipt of your letter of December 2, 2010 and find that it does not address the lack of control for the food safety hazard of parasites for your raw refrigerated fluke process. You indicate that the HACCP plan collected during the inspection is for a “primary processor” only and that you are not a primary processor. However, control of parasites in raw ready-to-eat fish that pose a hazard for parasites is the responsibility of the final processor, who is the entity selling the fish directly for raw consumption, rather than the responsibility of the primary processor who supplied the fish. In addition, you should conduct a hazard analysis on all your fish and fishery products, including those listed in HACCP plan #2, to determine whether parasites are reasonably likely as a hazard that needs to be controlled.
 

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 your Nigiri and sushi products at the “Finished Product Storage” critical control point to control pathogens and histamine/scombrotoxin is not appropriate. Specifically, your plan lists that you will “move product to another cooler”. However, our inspection revealed that your firm has only one cooler consequently; you will be unable to implement this corrective action.

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.
We have the following additional comments with regard to your HACCP plans:
 

1. With regard to your firm’s HACCP plan for “Nigiri and Sushi Rolls”, you must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and include in your HACCP plan adequate critical control points to control those hazards. A review of your processing operations reveals that your firm will likely need to list the combined critical control points for manufacturing the rolls, including thawing of raw materials, ingredient preparation, assembly, rolling, cutting and packaging/labeling cumulatively to control the food safety hazards of pathogen growth and histamine (i.e., in the rolls containing scombroid species). FDA recommends limiting the cumulative time for manufacturing of the rolls, to control pathogen growth and histamine; or alternatively, controlling and monitoring the temperature of the processing room, to prevent pathogen growth and histamine development.

2. With regard to your monitoring procedures at the “Receiving Finished Product Label” critical control point in your HACCP plan for “Nigiri and Sushi Rolls”, the procedure listed as “label COC on file” is not appropriate as a control method for your listed hazard of “Food allergens/label accuracy”. Your firm should be monitoring the actual labels and not the certificate of compliance (i.e., COC). For example, your firm should be conducting a visual check of one label from each lot of labels when receiving those labels to ensure that all allergenic substances are accurately listed on the labels for each finished Nigiri and sushi product.

3. We note that your HACCP plans #3, #4 and #10 which are those plans that cover raw fresh (not frozen) vacuum packed fish, include references to the presence of time/temperature indicators (TTIs), as well the requisite 38°F as the temperature critical limit necessary for control of Clostridium botulinum toxin in raw fresh fish. However, we note that your monitoring procedures for receipt of these products involve the monitoring of the TTIs to ensure that the TTI devices have not flipped color, indicating temperature abuse. Please be advised rather than monitoring the condition/color of the TTIs at receipt, FDA recommends that firms monitor receiving temperatures to ensure that the products have not been exposed to temperatures above 38°F during transit. Consequently, we recommend that your firm adopt a procedure to ensure that temperatures were continuously maintained at or below 38°F during transit to your facility, via continuous monitoring of product temperatures or continuous monitoring of the transport vehicle’s refrigeration unit.

4. In addition, we note that your various HACCP plans list varying temperature critical limits for cooler storage. For example, some plans list cooler storage temperatures at 38°F, (b)(4). It was revealed, however, during our inspection that your firm has only one cooler. Consequently, we recommend that because you will be storing all products in the same cooler, you set the cooler temperature to meet the most stringent temperature limit, i.e., the lowest temperature, in order to ensure that those products that need more stringent temperature controls are maintained and stored under safe conditions. For example, we recommend that you set your cooler temperature at or below 38° F.

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 Food and Drug Administration, Attention: Lori A. Holmquist, Compliance Officer, U.S. Food and Drug Administration, 330 Civic Center Drive, Suite 1, Box 4, Augusta, Maine 04330. If you have questions regarding any issues in this letter, please contact Ms. Holmquist at 207.622.8266 x13. 

 

Sincerely,

/S/

Mutahar S. Shamsi

District Director

New England District
 

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Close Out Letter

• True World Food Boston LLC - Close Out Letter 8/30/11

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Soluble Products Co., LP

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Waterview Corporate Center 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054   Telephone (973) 331-4905

March 25, 2011
 

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Stephen M. Hoffman
President and Owner
Soluble Products Co., LP
480 Oberlin Avenue South
Lakewood, NJ 08701-6903
 

File # 11-NWJ-14
 

Dear Mr. Hoffman:

On August 2-12, 2010, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility located at 480 Oberlin Avenue South in Lakewood, New Jersey. Our investigator found serious violations of 21 CFR Part 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
 

These violations cause your dietary supplements identified below to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that the dietary supplements have been prepared, packed, or held under conditions that do not meet cGMP regulations for dietary supplements. You may find the Act and the FDA's regulations through links in the FDA's home page at http://www.fda.gov.
 

The inspection revealed the following violations:
 

1. Your firm failed to establish component identity specifications for each component used in the manufacture of your dietary supplement, as required by 21 CFR 111.70(b)(1). Specifically, your firm did not establish identity specifications for each component used in the manufacture of the following dietary supplements:
 

• Revival Soy Pro Water Mix Vanilla Unsweetened, lot 04 11RUV A5
• Revival Soy Pro Water Mix Vanilla w/ Sucralose, lots 04 11RUV A5 and B5
• Revival Soy Pro Water Mix Chocolate w/ Sucralose, lot 04 11RAC A5, B5, and C5
• Revival Soy Pro Water Mix Chocolate w/ Fructose, lot 06 11RSC A5 and B5
• Revival Soy Pro Water Mix Vanilla w/ Fructose, lot 06 11RSV A5
• Revival Soy Pro Water Mix Chocolate Unsweetened, lot 10 11RUC A5
 

2. Your firm's Master Manufacturing Records (MMR) for the Revival Brand Unsweetened Chocolate (lot 10 11 RUCA5) dietary supplements did not include the following information, as required by 21 CFR 111.210:
 

• The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list [21 CFR 111.210(d)].
• A statement of the expected yield of the manufactured dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted, and disposition decision is made. [21 CFR 111.210(f)].
• A description of packaging and a representative label or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)].
• Specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR [21 CFR 111.210(h)(1)]. 

3. Your firm failed to verify that your finished batch of the dietary supplements meet product specifications for identity, purity, strength, and composition, as required by 21 CFR 111.75(c). Specifically, you did not verify that such finished product specifications were met for the Revival Brand Unsweetened Chocolate (lot 10 11RUCA5). You may verify that these specifications are met by testing or examining every finished batch or a subset of finished batches for each of the dietary supplements you manufacture [21 CFR 111.75(c)]. However, your firm did not conduct finished product testing to verify that established product specifications were met for such finished dietary supplement products.
 

4. Your firm failed to establish specifications to provide sufficient assurance that products your firm receives from a supplier for packaging or labeling and distribution as dietary supplements are adequately identified and are consistent
with your purchase order, as required by 21 CFR 111.70(f). Specifically, your firm receives from a supplier 8-count multivitamin blister packs that your firm repackages into finished products for distribution. However, your firm did not establish specifications to provide assurance that the 8-count multivitamin blister packs were adequately identified and consistent with your purchase order, as required by 21 CFR 111.70(f). 

We note that your firm does not do its own testing or examination of components that are not dietary ingredients and relies on a certificate of analysis for such components. In addition, we understand that you do not qualify any of the suppliers of such components used in your products by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations and maintain documentation of how you qualified the supplier. You are required to qualify a supplier that tests or examines components that are not dietary ingredients and maintain documentation of how you qualified the supplier. [21 CFR 111.75(a)(2)(ii)(A), 21 CFR 111.75(a)(2)((ii)(C)].
 

We also note that your firm does not retain reserve samples for the time required. Reserve samples are required to be retained for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve sample [21 CFR 111.83(b)(3)]. We understand that your firm retains reserve samples for two years from the date of manufacture.
 

This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you market comply with the Act and its implementing regulations.
 

Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
 

Please advise this office in writing within 15 days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
 

Please send your reply to U.S. Food and Drug Administration, 10 Waterview Blvd., Parsippany, New Jersey 07054, Attn: Joseph F. McGinnis R.Ph, Compliance Officer.
 

Sincerely,
/S/
Diana Amador-Toro
District Director
New Jersey District
 

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