| Public Health Service Food and Drug Administration |
| New York District 158-15 Liberty Avenue Jamaica, NY 11433 |
Department of Health and Human Services
May 19, 2011
WARNING LETTER NYK 2011-22
VIA FEDERAL EXPRESS
Vincent A. Bilow, Owner
Bilow Farms, LLC
1143 County Route 24
Malone, New York 12953-3966
Dear Mr. Bilow:
On January 10 and 13, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 1143 County Route 24, Malone, New York. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 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 the FDA's web page at www.fda.gov.
We found 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 April 13, 2010, you sold a dairy cow, identified with farm tag (b)(4), for slaughter as food. On or about April 14, 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 ampicillin in the kidney at 0.31 parts per million (ppm). FDA has established a tolerance of 0.01 ppm for residues of ampicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.40 (21 C.F.R. 556.40). In addition, our investigation revealed that on or about September 7, 2010, you sold a bob veal calf identified with sale tag (b)(4), for slaughter as food. On or about September 8, 2010, (b)(4) slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of gentamicin in the kidney tissue. FDA has not established a tolerance for residues of gentamicin in edible tissue of veal calves. The presence of these drugs in edible tissues from these animals in these amounts 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 you hold animals under conditions which 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 drug Gentafuse (Gentamicin Sulfate Solution), ANADA 200-395. Specifically, our investigation revealed you did not use this drug as directed by its approved labeling. Use of this drug in this manner is extralabel use as defined in 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 FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R Part 530. Extralabel use of approved animal or human drugs must be by or on the lawful order of a licensed veterinary within the context of a valid veterinarian/client/patient relationship.
Our investigation found you administered gentamicin sulfate to a bob veal calf contrary to your veterinarian's prescription labeling which stated not to administer to food producing animals. In addition, you administered gentamicin sulfate to a bob veal calf two days before the animal was slaughtered. According to scientific literature, the recommended withdrawal time for gentamicin sulfate is 18 months. Your extralabel use of gentamicin sulfate was not under the supervision of a licensed veterinarian, inviolation of 21 CFR 530.11(a) and your extralabel use of gentamicin sulfate resulted in an illegal drug residue in violation of 21 CFR 530.11(c). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused the drug 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 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.
Your written response should be sent to Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A. Clark at 716-551-4461, extension 3168.
Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District
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