Woodcrest Dairy Llc 3/20/14
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
March 20, 2014
WARNING LETTER NYK-2014-26
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Dr. Robert E. Cruikshank, DVM, Co-Owner
Peter R. Braun, Co-Owner
Woodcrest Dairy LLC
322 Wood Road
Lisbon, New York 13658-3277
Dear Dr. Robert Cruikshank and Mr. Peter Braun:
On January 23 & 30, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 322 Wood Road, Lisbon, 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.
We found that you offered for sale one animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
Specifically, our investigation revealed that on or about July 11, 2013, you sold a bob veal calf, identified with ear tags [(b)(4)] and [(b)(4)], for slaughter as food. On or about July 12, 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 8.14 parts per million (ppm) of neomycin residue in the kidney. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430(b)(1) (21 C.F.R. 556.430(b)(1)). However, this tolerance does not apply to the use of [(b)(4)] Type B Medicated Feed (neomycin sulfate and oxytetracycline hydrochloride) in bob veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of the drug [(b)(4)] medicated feed in bob veal calves (pre-ruminating calves). 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).
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. For example, you failed to maintain complete treatment records for calves that you medicate. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).
We also found that you adulterated the new animal drug [(b)(4)] medicated feed. Specifically, our investigation revealed that you did not use the [(b)(4)] medicated feed as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 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 veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered the [(b)(4)] medicated feed to your bob veal calf identified with ear tags [(b)(4)] and [(b)(4)] without following the animal class as stated in the approved labeling. Your extralabel use of [(b)(4)] medicated feed was in or on feed, in violation of 21 C.F.R. 530.11(b) and your extralabel use of [(b)(4)] medicated feed resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you caused this 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).
In addition, you adulterated [(b)(4)] medicated feed within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. 351(a)(6), when you failed to use the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Section 512 of the FD&C Act, 21 U.S.C. 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feed.
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 are in compliance with the law.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these 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 of receiving this letter, 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 Lillian C. Aveta, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Lillian C. Aveta at (718) 662-5576 or Email at Lillian.Aveta@fda.hhs.gov
Ronald M. Pace
New York District
Dr. David Smith, Director
Division of Animal Industry
New York State Department of Agriculture & Markets
10 B Airline Drive
Albany, New York 12235