Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/crossbrook-farm-06302014
Timestamp: 2019-09-21 15:12:36
Document Index: 209295043

Matched Legal Cases: ['§ 342', '§ 360', 'art 530', 'art 530', '§ 360', '§ 351']

Crossbrook Farm - 06/30/2014 | FDA
Crossbrook Farm - 06/30/2014
Crossbrook Farm June 30, 2014
WARNING LETTER NYK-2014-44
Mr. Jonathan S. Prokop, Co-owner
Mr. Richard Prokop, Co-owner
Ms. Sandra Prokop, Co-owner
862 Mill Valley Road
Dear Messrs. Prokop and Ms. Prokop:
On March 25, April 10, and May 15, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your farm located at 862 Mill Valley Road, Middleburgh, New York. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.
Specifically, our investigation revealed that on or about July 9, 2013, you sold a dairy cow, identified with ear tag (b)(4) and back tag (b)(4), for slaughter as food. On or about July 10, 2013, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of penicillin at 0.084 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulation (C.F.R.), Section 556.510 (21 C.F.R. 556.510). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402 (a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
We also found that you adulterated the new animal drug (b)(4) Penicillin G Procaine Injectable Suspension, U.S.P., NADA (b)(4). Specifically, our investigation revealed that you did not use (b)(4) Penicillin G Procaine Injectable Suspension, U.S.P., NADA (b)(4), as directed by its approved labeling. Use of this drug in this manner is an extralabel use, as defined under 21 C.F.R. 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinary within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered (b)(4) Penicillin G Procaine Injectable Suspension, U.S.P., NADA (b)(4), to a dairy cow without following the withdrawal period as stated in the approved labeling. Your extralabel use of (b)(4) Penicillin G Procaine Injectable Suspension, U.S.P., NADA (b)(4), was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of (b)(4) Penicillin G Procaine Injectable Suspension, U.S.P., NADA (b)(4), resulted in an illegal drug residue in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).