Inspections, Compliance, Enforcement, and Criminal Investigations
Beckman, Robert L. 7/9/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New York District|
158-15 Liberty Avenue
Jamaica, NY 11433
July 9, 2010
WARNING LETTER NYK-2010-22
VIA UNITED PARCEL SERVICE
Robert L. Beckman, Owner
7253 Bowers Road
Cassadaga, New York 14718
Dear Mr. Beckman:
On May 19, 20, and 28, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy firm located at 7253 Bowers Road, Cassadaga, New York. 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 the FDA's web page at www.fda.gov.
We found that you offered an animal for sale 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 anew 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 6, 2009, you sold a bob veal calf, identified with tag (b)(4) for slaughter as food. On or about October 9, 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 gentamicin sulfate in the liver, kidney, and muscle tissue. FDA has not established a tolerance for residues of gentamicin in edible tissue of veal calves. 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 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 (b)(4) (Gentamicin Sulfate (b)(4). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling. Use of this drug in this manner is extralabel use. 21 CFR 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 veterinary within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered gentamicin sulfate to a bob veal calf without following the animal species as stated in the approved labeling. Your extralabel use of gentamicin sulfate was not under the supervision of a licensed veterinarian, in violation 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 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.
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 Dean R. Rugnetta, 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 Dean Rugnetta at (716) 541-0324 or Email at email@example.com.
Ronald M. Pace
New York District