Inspections, Compliance, Enforcement, and Criminal Investigations
Adon Farms 8/5/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New York District|
158-15 Liberty Avenue
Jamaica, NY 11433
August 5 2009
WARNING LETTER NYK 2009-15
Via Federal Express
Andrew J. Gilbert
403 State Highway 72
Potsdam, New York 13676
Dear Mr. Gilbert:
On April 2 and 9, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 403 State Highway 72, Potsdam, New York 13676. 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 October 15, 2008, you sold a dairy cow, identified with farm tag#(b)(4) for slaughter. On or about October 16, 2008, (b)(4) slaughtered this animal. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.82 parts per million (ppm) of penicillin residue in the kidney tissue. FDA has established a tolerance for residues of penicillin in the uncooked edible tissues of cattle at 0.05 ppm as codified in Title 21, Code of Federal Regulations, Section 556.510(a) [21 C.F.R. 556.510(a)]. The presence of this drug in edible tissue from this animal 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 accurate treatment records and you lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. 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 drugs (b)(4) (Penicillin G Procaine Injectable Suspension), (b)(4) (ceftiofur hydrochloride), and (b)(4) (hetacillin potassium). Specifically, our investigation revealed that you did not use (b)(4) and (b)(4) 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 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 the drugs (b)(4) and (b)(4) without following the dosage levels as stated in the approved labeling. Your extralabel use of these drugs was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use of (b)(4) resulted in an illegal residue, in violation of 21 C.F.R. 530.11(d). In addition, you administered the drug (b)(4) without following the withdrawl period for slaughter set forth in the approved labeling. Specifically, you administered the drug (b)(4) on October 9, 2008, and then sold the dairy cow identified with farm tag # (b)(4) for slaughter on October 15, 2008. The approved labeling of (b)(4) states treated animals must not be slaughtered for food until ten days after the latest treatment. Because your extralabel use of these drugs was not in compliance with 21 C.F.R. Part 530, these drugs were unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and your use caused them to be 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 are 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, 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 Dean Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, NY 14202. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at 716-541-0324 or email@example.com.
Otto D. Vitillo
New York District
Enclosures 21 C.F.R. 556.510
21 C.F.R. Part 530