| Public Health Service Food and Drug Administration |
PHILADELPHIA DISTRICT |
Department of Health and Human ServicesWARNING LETTER
11-PHI-07
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
February 15, 2011
Mr. Lloyd B. Zimmerman, Owner
Lloyd B. Zimmerman and Sons
2413 Snydertown Road
Danville, Pennsylvania 17821-7429
Dear Mr. Zimmerman:
On October 28, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 2413 Snydertown Road, Danville, PA. 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 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. 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 May 5, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about May 5, 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 neomycin in the kidney at 15.14 parts per million (ppm). FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, Section 556.430(b)(1) (21 C.F.R. 556.430(b)(1)). However, this tolerance does not apply to the use of (b)(4) Vigormilk 22BNT Medicated Milk Replacer containing oxytetracycline, and neomycin in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of (b)(4) Vigormilk 22BNT Medicated Milk Replacer containing oxytetracycline, and neomycin in veal calves (pre-ruminating calves). Therefore, the presence of this drug in kidney 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).
In addition, our investigation revealed that on or about July 14, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about July 14, 2010, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of neomycin in the kidney at 11.51 ppm. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in 21 C.F.R. 556.430(b)(1). However, this tolerance does not apply to the use of (b)(4) Vigormilk 22BNT Medicated Milk Replacer containing oxytetracycline, and neomycin in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of (b)(4) Vigormilk 22BNT Medicated Milk Replacer containing Oxytetracycline, and neomycin in veal calves (pre-ruminating calves). Therefore, the presence of this drug in kidney 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 the new animal drugs oxytetracycline, and neomycin that were contained in the (b)(4) Vigormilk 22BNT Medicated Milk Replacer. Specifically, our investigation revealed that you did not use (b)(4) Vigormilk 22BNT Medicated Milk Replacer as directed by its 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 the new animal drugs Oxytetracycline, and neomycin that were contained in the (b)(4) Vigormilk 22BNT Medicated Milk Replacer to your bob veal calves without following the animal class as stated in the approved labeling. Your extralabel use of the new animal drugs oxytetracycline, and neomycin that were contained in the (b)(4) Vigormilk 22BNT Medicated Milk Replacer was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of these drugs in the (b)(4) Vigormilk 22BNT Medicated Milk Replacer was not in conformance with its 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.
We are aware that you sold two bob veal calves on or about October 6, 2010, that contained 10.2 ppm of neomycin in the kidney tissue of one bob veal calf, identified with back tag (b)(4), and the presence of gentamicin in the kidney tissue of one bob veal calf, identified with back tag (b)(4). FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in 21 C.F.R. 556.430(b)(1). FDA has not established a tolerance for gentamicin in the edible tissues of cattle.
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 Robin Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Rivers at (215) 717-3076 or E-mail at robin.rivers@fda.hhs.gov.
Sincerely,
/s/
Kirk D. Sooter
District Director
Philadelphia District
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