Inspections, Compliance, Enforcement, and Criminal Investigations
Pastime Lakes Dairy
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612·2606
RETURN RECEIPT REQUESTED
November 8, 2010
John H. TeVelde, Partner
Pastime Lakes Dairy
34450 Ramona Expressway
Lakeview, California 92567-9115
Dear Mr. TeVelde:
On August 26 and September 21, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 34450 Ramona Expressway, Lakeview, California. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (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 April 6, 2010, you sold a cow, identified with ear tag 2284 (back tag 93GG5809), for slaughter as food. On or about April 6, 2010, American Beef Packers Inc. 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 0.162 parts per million (ppm) of flunixin in the liver tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in liver tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.286 (21 C.F.R. § 556.286). The presence of this drug in edible tissues 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 the new animal drugs Polyotic Soluble Powder NADA 065269 (Tetracycline Hydrochloride) and Flunazine Injectable Solution ANDA 200-387 (Flunixin Meglumine). Specifically, our investigation revealed that you did not use tetracycline hydrochloride and flunixin meglumine 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 flunixin meglumine to a dairy cow without following the dose as stated in your veterinarian's prescribed labeling. Our investigation also found that you administered tetracycline hydrochloride via the uterus of cows without following the route of administration as stated in the approved labeling. Your extralabel use of flunixin meglumine and tetracycline hydrochloride was not under the supervision of a license veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of flunixin meglumine resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(d). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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.
Please send your reply to the Food and Drug Administration, Attention:
Los Angeles District
Irvine, CA 92612-2506
If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439,
Alonza E, Cruse
cc: Sheryll TeVelde, Partner
Pastime Lakes Dairy
34450 Ramona Expressway
Lakeview, CA 92567-9115
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P,O. Box 997412
Sacramento, CA 95899-7413
California Department of Food and Agriculture
Animal Health and Food Safety Services
Milk and Dairy Food Safety Branch
1220 N. Street
Sacramento, CA 95814