| Public Health Service Food and Drug Administration |
| Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4416 |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
February 9, 2010
W/L 09-10
Mr. Peter Bouma, Dairy Partner
Mr. Sam Dekruyf, Dairy Partner
P & D Dairy
8919 Merrill Avenue
Chino, California 91710-8511
Dear Messrs. Bouma and Dekruyf:
On June 29, July 1, and October 22, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8919 Merrill Avenue, Chino, California 91710-8511. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.
We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about May 4, 2009, you sold a culled dairy cow, identified with ear tag #(b)(4) (back tag (b)(4), for slaughter as food. On or about May 5, 2009, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 1.177 parts per million (ppm) of sulfadimethoxine residue in the liver. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.). 556.640 (21 C.F.R. 556.640). 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 Act, 21 U.S.C. 342(a)(2)(C)(ii).
Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).
We also found that you adulterated the new animal drug penicillin G procaine (Injectable Suspension). Specifically, our investigation revealed that you did not use penicillin G procaine as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered penicillin G procaine to the culled dairy cow identified with ear tag #(b)(4) without following the indications for use as stated in the approved labeling. Furthermore, your extralabel use of penicillin G procaine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.1 1(a). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5).
The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
Our investigation also revealed that on or about March 4, 2009, you provided (b)(4) with a signed bill of sale or consignment certifying that, among other things, none of the cattle have an illegal level of drug residue. This signed bill of sale or consignment covered the dairy cow identified with ear tag#(b)(4) which was found to have a violative sulfadimethoxine residue. Providing such a false guaranty is prohibited by section 301(h) of the Act, 21 U.S.C. 331(h). You should take appropriate actions to ensure that this violation does not recur.
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:
Acting Director of Compliance
U.S. Food and Drug Administration
19701 Fairchild
Irvine, California 92612.
If you have any questions about this letter, please contact Compliance Officer William S. Vitale at (949) 608-2919 or Email at bill.vitale@fda.hhs.gov.
Sincerely yours,
/S/
Alonza E. Cruse
District Director
Los Angeles District
Enclosure(s)
cc: California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413
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