Public Health Service
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
November 20, 2014
WARNING LETTER NYK-2015-10
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. Randall A, Ooms, Co-Owner
Mrs. Elizabeth Ooms, Co-Owner
221 Powers Road
Constable, New York 12926-3722
Dear Mr. and Mrs. Ooms:
On September 9 and 17, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 221 Powers Road, Constable, 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 May 29, 2014, you sold a cow, identified with tags (b)(4), for slaughter as food. On or about May 30, 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 8.25 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney. FDA has established a tolerance of 0.4 parts per million (ppm) for residues of desfuroylceftiofur in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113(b)(3)(i) (21 C.F.R. 556.113(b)(3)(i)). 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 and you held expired drugs in your drug inventory. 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).
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.
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 Catherine M. Beer, Compliance Officer, U.S. Food and Drug Administration, 1 Winners Circle, Suite 110, Albany, New York 12205. If you have any questions about this letter, please contact Compliance Officer LCDR Catherine M. Beer at (518) 453-2314 x1015 or Email at Catherine.email@example.com.