Inspections, Compliance, Enforcement, and Criminal Investigations
Kevin Sharpe Farm 06-Jun-07
Department of Health and Human Services
Public Health Service
New York District
June 6, 2007
WARNING LETTER NYK 2007-16
RETURN RECEIPT REQUESTED
Kevin A. Sharpe, Owner
Kevin Sharpe Farm
6473 Haights Gulf Road
Cortland, New York 13045-9772
Dear Mr. Sharpe:
An investigation of your dairy operation located at 6473 Haights Gulf Road, Cortland, New York, conducted by a representative of the U.S. Food and Drug Administration (FDA) on February 28 and March 5, 2007, confirmed that you offered animals for sale for slaughter as food that were adulterated under section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Federal Food, Drug and Cosmetic Act (the Act). The investigation also revealed you caused the new animal drug, [redacted] Sterile Penicillin G Procaine Injectable Suspension [redacted], to become unsafe under section 512 [21 U.S.C. § 360b] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.
On or about December 11, 2006, you consigned a dairy cow with farm tag 466 for slaughter as food at [redacted]. On or about December 12, 2006, this animal was slaughtered at [redacted]. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.15 parts per million (ppm) of penicillin in kidney tissue. On or about January 10, 2007, you consigned a second dairy cow with Sales Rail Tag G 57 for slaughter as food at [redacted]. On or about January 11, 2007 this animal was slaughtered at [redacted] USDA/FSIS analysis, of tissue samples collected that animal identified presence of 0.33 ppm of penicillin in kidney tissue. A tolerance of 0.05 ppm has been established for residues of penicillin in edible tissue of cattle, as codified in Title 21, Code of Federal Regulations. Section 556.510(a) [21 CFR 556.510(a)]. The presence of this drug in edible tissue from these animals in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.
In addition you adulterated [redacted] Sterile Penicillin G Procaine Injectable Suspension [redacted] within the meaning of section 501(a)(5) [21 U.S.C. § 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 animal or human drugs must comply with sections 512(a)(4) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and 21 CFR Part 530.
Our investigation found that your extralabel use of [redacted] Sterile Penicillin G Procaine Injectable Suspension [redacted] failed to comply with these requirements. For example, you administered the [redacted] Sterile Penicillin G Procaine Injectable Suspension [redacted] without following the dosage level and you did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(d). Because your extralabel use of this drug was not in compliance with 21 CFR Part 530, your use caused the drug to be unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 301(a)(5)] of the Act.
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 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 James M. Kewley, 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 James M. Kewley at (716) 551-4461, ext. 3128.
Otto D. Vitillo
New York District