Inspections, Compliance, Enforcement, and Criminal Investigations
WaJa Farms, Inc 06-Dec-05
Department of Health and Human Services
Public Health Service
New York District
December 6, 2005
WARNING LETTER NYK 2006-02
RETURN RECEIPT REQUESTED
Walter E. Newton III, President
WaJa Farms, Inc.
State Route 2010
New Albany, PA 18833
Dear Mr. Newton:
An investigation of your veal calf operation conducted by a representative of the U.S. Food and Drug Administration on August 22 & 25, 2005 and September 2, 2005, confirmed that you offered an animal for sale for slaughter as food that was adulterated under section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342 (a)(2)(C)(ii)]. The inspection also revealed that 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) of the Act [21 U.S.C. 351(a)(5)] and unsafe within the meaning of section 512 of the Act [21 U.S.C. 360b]. You can find the Act and its associated regulations on the Internet through links in FDA's web page at www.fda.gov.
Our investigation found that you caused the adulteration of the new animal drugs Neomycin 325 Soluble Powder and Pen-Aqueous Sterile Penicillin G Procaine Injectable Suspension within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)] when, in accordance with your instructions, the contract grower failed to use the drugs in conformance with their 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 the extralabel use of Neomycin 325 Soluble Powder in starter formula fed to your veal calves, and the extralabel use of Pen-Aqueous Sterile Penicillin G Procaine Injectable Suspension in the treatment of your veal calves, failed to comply with these requirements.
For example, in accordance with your start up protocol, contract grower [redacted] added Neornycin 325 Soluble Powder supplied by your firm, to starter formula fed to your veal calves. Veal calves are a class of animals specifically excluded in the approved drug labeling, and this administration was done without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). You also 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 an animal feed. By supplying the drug Pen-Aqueous Sterile Penicillin G Procaine Injectable Suspension to your contract veal grower [redacted] along with a "DRUG DOSAGE AND WITHDRAWAL" protocol for its use, you caused that drug to be used in veal calves, a class of animals for which it is not approved, and this administration was done without the supervision of a licensed veterinarian, in violation of 21 CFR 530 .11(a). Because the extralabel use of these drug 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 its use caused them to be adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. 301(a)(5)]. You also caused the adulteration of an animal feed under Section 501(a)(6) of the Act [21 U.S.C. 351(a)(6)].
In addition, per your instructions on or about May 24, 2005, a veal calf owned by your firm was shipped from a contract grower [redacted] 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 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)].
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, the operation of firms contracted to grow your veal calves, and the food you distribute, are in compliance with the law.
You should take prompt action to correct the above violations, including violations at firms contracted to grow your veal calves, 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