Inspections, Compliance, Enforcement, and Criminal Investigations
Michael Mumbulo 08-Dec-05
Department of Health and Human Services
Public Health Service
New York District
December 8, 2005
WARNING LETTER NYK 2006-03
RETURN RECEIPT REQUESTED
414 Vibbard Road
Edmeston, NY 13335
Dear Mr. Murnbulo:
An investigation of your veal calf operation conducted by a representative of the U.S. Food and Drug Administration on August 5, 8, 17 & 30, 2005, confirmed you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed you caused the new animal drugs Neomycin 325 Soluble Powder and Pen-Aqueous Sterile Penicillin G Procaine Injectable Suspension to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] and unsafe within the meaning of section 512 [21 U.S.C. 360b] of the Act. You can find the Act and its associated regulations on the Internet through links in FDA's web page at www.fda.gov.
On or about May 24, 2005, a veal calf was shipped from your farm to [redacted] for slaughter for human food. On or about May 25, 2005, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 1.90 ppm neomycin in kidney tissue. Neomycin is not approved for use in veal calves, see 21 CFR 520.1484. The extralabel use of neomycin in veal calves, without complying with Section 512(a)(4) of the Act [21 U.S.C. 360b(a)(4)] and the extralabel use regulations in 21 CFR Part 530, causes the drug to be unsafe within the meaning of Section 512 of the Act [21 U.S.C. 360b]. The presence of this unsafe 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 you hold animals under conditions so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, 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 drugs from edible tissues . You failed to maintain complete treatment records, and you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals. Food from animals held under such conditions is adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C.
In addition, you adulterated the new animal drug Neomycin 325 Soluble Powder within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)] when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. 360b(a)(4), (5)] and 21 C.F.R. Part 530. Our investigation found that your extralabel use of Neomycin 325 Soluble Powder failed to comply with these requirements.
For example, you administered Neomycin 325 Soluble Powder to starter formula and fed the medicated formula to veal calves, a class of animals for which the drug is specifically excluded by the approved labeling instructions, and you did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11 (a). You used neomycin in starter formula, which is an animal feed, in violation of 21 CFR 530.11(b), which prohibits the extralabel use of drugs in or on animal feed. In addition, you administered Pen-Aqueous Sterile Penicillin G Procaine Injectable Suspension to veal calves, contrary to label instructions, which specifically prohibit its use in calves to be processed for veal, and you did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Because your extralabel use of these drugs was not in compliance with 21 CFR Part 530, the 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) [21 U.S.C. 301(a)(5)] of the Act. You also caused the adulteration of an animal feed under section 501(a)(6) of the Act [21 U.S.C. 351(a)(6)].
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 above violations and to establish procedures whereby such 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 timeframe 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 Compliance Officer James M. Kewley at the above address . If you have any questions about this letter, please contact Mr. Kewley at the above address or by phone at (716) 541-0328.
Jerome G. Woyshner
Director, New York District