Inspections, Compliance, Enforcement, and Criminal Investigations
Ben J. Weaver 21-Sep-07
Department of Health and Human Services
Public Health Service
New York District
September 21, 2007
WARNING LETTER NYK 2007-19
RETURN RECEIPT REQUESTED
Ben J. Weaver
8944 Cherry Hill Road
Clymer, New York 14724
Dear Mr. Weaver:
An inspection of your veal calf raising operation located 8944 Cherry Hill Road, Clymer, New York, was conducted by representatives of the U.S. Food and Drug Administration (FDA) on January 11, 22 and April 23, 2007. FDA inspectors gathered further evidence on June 13, 2007. The inspection of your facility confirmed that you caused the new animal drug Duo Pen (Penicillin G Benzathine and Penicillin G Procaine Injectable Suspension) to become unsafe under section 512 [21 U.S.C. 360b] and adulterated within the meaning of section 501(a)(5)[21 U.S.C. 351(a)(5)] of the Act. In addition, that inspection confirmed that you caused animal feed to become unsafe under section 512 of the Act [21 U.S.C. 360b] and adulterated within the meaning of section 501(a)(6) [21 U.S.C. 351(a)(6)] and of the Act, by adding NeoMed 325 Soluable Powder (Neomycin Sulfate) and Uniprim Powder for Horses (Trimethoprim and Sulfadiazine) to the Strauss Veal Feed Market Blend milk replacer fed to your calves. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
You adulterated Duo Pen (Penicillin G Benzathine and Penicillin G Procaine Injectable Suspension) within the meaning of section 501(a)(5) [21 USC 351(a)(5)] of the Act 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 section 512(a)(4)[21 USC 360b(a)(4)] and section 512(a)(5) [21 USC 360b(a)(5)] of the Act and Title 21, Code of Federal Regulations (21 CFR), Part 530. Our investigation found that your extralabel use of this drug failed to comply with these requirements.
Specifically, you treated the calf bearing tag 904 with 10 cc Duo Pen (Penicillin G Benzathine and Penicillin G Procaine Injectable Suspension) subcutaneously for a navel infection each day between September 18 and 30, 2006. The approved labeling instructions state, "Do not use in calves to be processed for veal." Your veterinarian's protocol instructed you to administer [redacted] to treat ear and navel infections with a [redacted] withdrawal period before slaughter. The sales invoices indicates the calf weighed 176 pounds at the time of sale. Nevertheless, you treated this veal calf at a higher dose and higher frequency than prescribed by your veterinarian, and you shipped this veal calf for slaughter on October 17, 2006 -- only 17 days after the last treatment. You administered this drug contrary to both the approved labeling instructions and those of your veterinarian.
In addition, you adulterated the animal feed that you fed to your veal calves within the meaning of section 501(a)(6) of the Act [21 U.S.C. 351 (a)(6)] by adding NeoMed 325 Soluable Powder (Neomycin Sulfate) and Uniprim Power for Horses (Trimethoprim and Sulfadiazine) to Strauss Veal Feed Market Blend milk replacer. The extralabel use of drugs in or on animal feed is specifically prohibited by section 512(a)(4) [21 USC 360b(a)(4)] of the Act, and 21 CFR Part 530.
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 be aware that your illegal extralabel use of drugs resulted in high levels of drug residues in the edible tissues of veal calves you offered for slaugthter.
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 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.
Otto D. Vitillo
New York District