Inspections, Compliance, Enforcement, and Criminal Investigations
Petrie Farms 14-Apr-06
Department of Health and Human Services
Public Health Service
300 Pearl Street, Suite 100
April 14, 2006
WARNING LETTER NYK 2006-14
RETURN RECEIPT REQUESTED
Daniel J. Petrie, Owner
5030 Sheehe Road
Arcade, NY 14009-9750
Dear Mr. Petrie:
An investigation of your dairy operation located at Arcade, New York was conducted by a representative of the U.S. Food and Drug Administration (FDA) on January 3, 10, and 17, 2006. This investigation confirmed that 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 that you caused the new animal drug, [redacted] Penicillin G Procaine Injectable Suspension (NADA [redacted] to become unsafe under section 512 of the Act [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. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about October 31, 2005, you consigned a dairy cow, identified with ear tag [redacted] farm tag [redacted] for slaughter for human food. This animal was slaughtered November 1, 2005, 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 penicillin at 0.08 parts per million (ppm) in kidney tissue and sulfadimethoxine at 0.37 ppm in liver tissue and 0.15 ppm in muscle tissue. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (CFR), Section 556.510 (21CFR 556.510). The presence of this drug in these amounts in the edible tissues of this animal 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)].
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. 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 residues of drugs from edible tissues. For example, your treatment records do not include the associated withdrawal time. 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)].
In addition, you adulterated [redacted] Penicillin G Procaine Injectable Suspension (NADA [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 veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act and 21 CFR Part 530.
Our investigation found that your extralabel use of [redacted] Penicillin G Procaine Injectable Suspension (NADA [redacted]) failed to comply with these requirements. For example, you administered the [redacted] Penicillin G Procaine Injectable Suspension (NADA [redacted]) without following the dosage level set forth in its approved labeling. Furthermore, your extralabel use resulted in illegal drug residues, in violation of 21 CFR 530.11(d) and you did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). 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) 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. § 301(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 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 response should be sent to John D. White, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl St., Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer John D. White at (716) 541-0362.
Joseph F. McGinnis
Acting District Director
New York District