Peyerk Brothers Dairy LLC 8/15/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Detroit District|
300 River Place
Detroit, MI 48207
August 15, 2013
Robert F. Peyerk, Co-Owner
Bradley R. Peyerk, Co-Owner
Peyerk Brothers Dairy LLC
2208 North Parisville Road
Harbor Beach, Michigan 48441
Dear Mr. Peyerk:
On June 19 and June 28, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2208 North Parisville Road, Harbor Beach, Michigan. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 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. 360(b). 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 October 16, 2012 you sold a dairy cow with back tag (b)(4), ear tag (b)(4), and retain tag (b)(4) for slaughter as food. On or about October 17, 2012, (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 desfuroylceftiofur at a level of 6.92 ppm in the kidney. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113(b)(3) (21 C.F.R. 556.113(b)(3)). The presence of this drug in the edible tissues from this animal in these amounts causes the food to be adulterated under 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 Excede (Ceftiofur Crystalline Free Acid) NADA 141-209 and Vetrimycin 100 mg (oxytetracycline HCl) ANADA 200-452. Specifically, our investigation revealed that you did not use Excede and Vetrimycin as directed by their approved labeling. Use of these drugs 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 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 Excede to a dairy cow with ear tag (b)(4) without following the withdrawal period and the indication for use, as stated on the labeling. Your extralabel use of Excede was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Excede resulted in an illegal drug residue in violation of 21 C.F.R. 530.11(d). Also, our investigation found that you administered Vetrimycin to your dairy cows without following the route of administration, as stated on the labeling. Your extralabel use of Vetrimycin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of these drugs was not in conformance with the 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 with 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.
Our investigation also revealed that on or about February 14, 2012 you provided to (b)(4), a signed certification that states that the livestock you sell do not have illegal levels of drug residues. According to the certificate, it remains in effect until the undersigned delivers written notice of revocation to the (b)(4) market / staff. On or about October 16, 2012 you delivered a dairy cow identified with ear tag (b)(4), which contained violative residues of desfuroylceftiofur, to (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C 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.
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Your written response should be sent to LCDR Kelli Wilkinson, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact LCDR Wilkinson at 313-393-8120.
Glenn T. Bass
Detroit District Office