- Animal & Veterinary
- Woody Hill Farms
- Issuing Office:
- New York District Office
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
JULY 29, 2015
WARNING LETTER NYK-2015-43
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Ms. Jennifer L. Cary, Co-Owner
Mr. Mark L. Cary, Co-Owner
Mr. Daniel Sheldon, Co-Owner
Mr. James Sheldon, Co-Owner
Woody Hill Farms
4330 State Route 22
Salem, New York 12865-3426
Dear Mr. and Mrs. Cary and Messrs. Sheldon:
On April 22, April 29, and May 12, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at
4330 State Route 22, Salem, 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 an 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 September 11, 2014, you sold a bob veal calf, identified with ear tag #(b)(4) and retain tag #(b)(4), for slaughter as food. On or about September 12, 2014, (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 sulfadimethoxine in the kidney tissue. FDA has established a tolerance of 0.1 part per million (ppm) for residues of sulfadimethoxine in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.640(b)(1) (21 C.F.R. 556.640(b)(1)). However, this tolerance does not apply to the use of (b)(4) (sulfadimethoxine), ANADA (b)(4), in calves to be processed for veal, and there is no acceptable level of residue associated with the use of (b)(4) (sulfadimethoxine), ANADA (b)(4), in calves to be processed for veal. 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 the calves treated. Your records did not include the drug dosage, route of administration, meat/milk withdrawal time, or who administered the drug. 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), ANADA (b)(4). Specifically, our investigation revealed that you did not use sulfadimethoxine as directed by its approved labeling or veterinarian’s order. 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 also found that you administered sulfadimethoxine to a bob veal calf with ear tag #(b)(4) without following the withdrawal period as stated in the veterinarian’s order. Your extralabel use of sulfadimethoxine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of sulfadimethoxine 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 or veterinarian’s order, 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).
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 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.
We received your written response dated May 27, 2015, from Ms. Jennifer Cary, Co-Owner, which included a letter describing your firm’s corrections to the FDA-483 observations. While we acknowledge that you have updated your treatment records, you failed to include documents showing your updated procedures for entering treatments. You did not address how you will ensure that all four co-owners, as well as your employees that have previously entered records in Spanish, will work together to ensure that medicated animals bearing potentially harmful drug residues will not enter the food supply.
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 LCDR Kristen C. Jackson, 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 LCDR Kristen C. Jackson at (718) 662-5711 or Email at Kristen.Jackson@fda.hhs.gov
Ronald M. Pace
New York District