Inspections, Compliance, Enforcement, and Criminal Investigations
Andrew Kiraly 11/18/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New York District|
158-15 Liberty Avenue
Jamaica, NY 11433
November 18, 2013
WARNING LETTER NYK-2014-6
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. Andrew L. Kiraly
188 Kiraly Road
Walton, New York 13856
Dear Mr. Kiraly:
On August 20, 22, 27 and 29, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 188 Kiraly Road, Walton, 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 the FDA's web page at http://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 January 9, 2013, you sold a bob veal calf, identified with sale tag (b)(4), for slaughter as food. On or about January 11, 2013, (b)(4) located at (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 sulfamethazine at 18.47 parts per million (ppm) in the liver tissue and 13.97 in the muscle tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.670 (21 C.F.R. 556.670). However, this tolerance does not apply to the use (b)(4) (sulfamethazine), NADA (b)(4) in bob veal calves (pre-ruminating calves). There is no acceptable level of residue associated with the use of (b)(4) in veal calves (pre-ruminating calves). The presence of this drug in edible tissue from this animal in the amount noted above 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 treatment records. Food from animals held under such conditions is adulterated within in 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) (sulfamethazine), NADA (b)(4). Specifically, our investigation revealed that you did not use (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 veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered (b)(4) to your bob veal calf, identified with sale tag (b)(4), without following the animal class as stated on the approved labeling. Your extralabel use of (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) resulted in illegal residues, 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 C.F.R. 530, you cause 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 acknowledge receipt of your September 5, 2013 letter responding to the violative levels of drug residues found in your bull calf (back tag (b)(4) and our inspectional findings related to this violation reported to you in our Inspectional Observations Form FDA 483 issued on August 29, 2013. We can only determine the effectiveness of your corrective actions over time.
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, New York District Office, Food and Drug Administration, 158-15 Liberty Ave., Jamaica, New York 11433. If you have any questions about the content of this letter please contact Ms. Aveta at 718-662-5576 or E-mail at email@example.com.
Ronald M. Pace
New York District