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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Lewis Livestock & Veal Company 8/16/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

San Francisco District
Pacific Region
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone:510-337-6700
         FAX: 510-337-6701
 

UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED

Our Reference: 3009242726

 
WARNING LETTER

August 16, 2012


Nathan W. Lewis, Co-Owner
Lindsey B. Plett, Co-owner
Lewis Livestock & Veal Company
8530 Keyes Road
Hughson, California 95326

Dear Mr. Lewis and Ms. Plett:

On May 23 and 25, and June 15 and 18, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your calf buying operation located at 8530 Keyes Road, Hughson, California.  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 seven animals for slaughter as food that were 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.

Specifically, our investigation revealed that on September 25, 2011, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food.  On September 25, 2011, (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 sulfamethoxazole at .471 parts per million (ppm) in the liver and 1.418 ppm in the muscle tissue. Sulfamethoxazole is a human drug and a safe tolerance level has not been established for the edible tissues of cattle. The presence of this drug in the edible tissues from this animal 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).   

On November 27, 2011, you sold another bob veal calf, identified with back tag (b)(4), for slaughter as food. On November 27, 2011, (b)(4) slaughtered this animal.  USDA/FSIS analysis of tissue samples collected from this animal identified the presence of flunixin at 0.589 ppm in the liver tissue.  A tolerance level has not been established in pre-ruminating veal calves for residues of flunixin. The presence of this drug in the edible tissues from this animal 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).  

On December 8, 2011, you sold another bob veal calf, identified with ear tag (b)(4), for slaughter as food.  On December 8, 2011, (b)(4) slaughtered this animal.  USDA/FSIS analysis of tissue samples collected from this animal identified the presence of neomycin at 28.84 ppm in the kidney tissue.  A tolerance of 7.2 ppm in the kidney has been established for residues of neomycin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.430 (21 C.F.R. 556.430). The presence of this drug above the safe tolerance level in the edible tissues from this animal 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).    

On December 9, 2011, you sold another bob veal calf, identified with back tag (b)(4), for slaughter as food.  On December 9, 2011, (b)(4) slaughtered this animal.  USDA/FSIS analysis of tissue samples collected from this animal identified the presence of neomycin at 71.88 ppm in the kidney tissue.  A tolerance of 7.2 ppm in the kidney has been established for residues of neomycin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.430 (21 C.F.R. 556.430).  The presence of this drug above the safe tolerance level in the edible tissues from this animal 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).    

On December 12, 2011, you sold another bob veal calf, identified with ear tag (b)(4), for slaughter as food.  On December 12, 2011, (b)(4) slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of neomycin at 82.68 ppm in the kidney tissue.  A tolerance of 7.2 ppm in the kidney has been established for residues of neomycin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.430 (21 C.F.R. 556.430).  The presence of this drug above the safe tolerance level in the edible tissues from this animal 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).

On December 23, 2011, you sold another bob veal calf, identified with back tag (b)(4), for slaughter as food. On December 23, 2011, (b)(4) slaughtered this animal.  USDA/FSIS analysis of tissue samples collected from this animal identified the presence of neomycin at 19.99 ppm in the kidney tissue.  A tolerance of 7.2 ppm in the kidney has been established for residues of neomycin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.430 (21 C.F.R. 556.430). The presence of this drug above the safe tolerance level in the edible tissues from this animal 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).    

On February 1, 2012, you sold another bob veal calf, identified with back tag (b)(4), for slaughter as food. On February 1, 2012, (b)(4) slaughtered this animal.  USDA/FSIS analysis of tissue samples collected from this animal identified the presence of sulfamethoxazole at .056 ppm in the liver and .170 in the muscle tissue.  Sulfamethoxazole is a human drug and a safe tolerance level has not been established for the edible tissues of cattle. The presence of this drug in the edible tissues from this animal 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).

You should take prompt action to correct the violations described in this letter and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction. The violations listed above are not intended to be an all-inclusive list. It is your responsibility to assure that your operations are in compliance with the law. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce, the adulterated animal. As such, you share the responsibility for violating the Federal Food, Drug and Cosmetic Act. To avoid future illegal residue violations you should take precautions such as:

1. Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal.
2. Implementing a system to determine from the source of the animal whether the animal has been medicated and with what drug(s); and
3. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete   potentially hazardous residues of drugs from edible tissues. If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.

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 Lawton W. Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, at 1431 Harbor Bay Parkway, Alameda, California 94502.  If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 1114 or via e-mail at Karen.Robles@fda.hhs.gov.

Sincerely,

/S/

Barbara J. Cassens
District Director
San Francisco District