Inspections, Compliance, Enforcement, and Criminal Investigations
Papas Dairy, LLC 11-Jan-08
Department of Health and Human Services
Public Health Service
New York District
January 11, 2008
WARNING LETTER NYK 2008-05
RETURN RECEIPT REOUESTED
Aaron G. Poupore, Co-Owner/Herdsman
Papas Dairy, LLC
322 Wheeler Road
North Bangor, New York 12966
Dear Mr. Poupore:
An inspection of your dairy operation located at 322 Wheeler Road, North Bangor, New York, conducted by a representative of the U.S. Food and Drug Administration (FDA) on October 17-19, 2007, confirmed that you offered a cow 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 drugs, ALBON® (sulfadimethoxine) boluses and penicillin G procaine, 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 September 11, 2007, you consigned a cow identified with farm [redacted] for slaughter as food to [redacted] where it was picked up the next day by [redacted]. On or about September 13, 2007, 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 cow identified the presence of 0.60 parts per million (ppm) of sulfadimethoxine in liver tissue and 0.41 ppm of sulfadimethoxine in muscle tissue. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.640(21 C.F.R. 556.640). The presence of this drug in these amounts in the uncooked 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)] of the Act.
Our investigation also found that you hold animals under conditions that are so in adequate 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, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning ofsection402(a)(4)[21 U.S.C. §342(a)(4)] of the Act.
In addition, you adulterated Albon® sulfadimethoxine boluses and Penicillin G Procaine within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use these 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 used of approved veterinary 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 C.F.R. Part 530. Our investigation found that your extralabel use of Albon® sulfadimethoxine boluses and Penicillin G Procaine failed to comply with these requirements.
For example, you administered Albon® sulfadimethoxine without following the dosage level set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore,your extralabel use resulted in an illegal residue, in violation of 21 C.F.R. 530.11(d). In addition, you administered IBA Penicillin G Procaine Injectable Suspension to cows on your farm without following the dosage level, route of administration, and duration of treatment set forth in the approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extralabel use of these drugs was not in compliance with 21 C.F.R. Part 530, the drugs were unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and your use caused them to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(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 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 Edward W. Thomas,Director Compliance Branch, 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 Mr. Thomas at (716) 541-0316
Otto D. Vitillo
Director, New York District