Head Farms 11/19/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty AvenueJamaica, NY 11433
November 19, 2013
WARNING LETTER NYK-2014-7
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Henry Albert Day, Co-Owner
5720 County Road 30
Canandaigua, NY 14424
Dear Mr. Day:
On August 19 through August 29, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 5720 County Road 30, Canandaigua, New York, 14424. 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 January 2, 2013, you sold a bob veal calf, identified with Sales Tag # (b)(4), for slaughter as food. On or about January 3, 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 sulfamethoxazole in the kidney tissue. FDA has not established a tolerance for residues of sulfamethoxazole in the edible tissues of veal calves. The presence of this drug in edible tissue from this animal 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. Your treatment records lack the indication for use, route administered, dosage frequency, duration of treatment, and the drug withdrawal time for meat. 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 human drug (b)(4), NDC (b)(4). Specifically, our investigation revealed that you did not use (b)(4) as directed by your veterinarian. Use of this drug in this manner is an extralabel use. See Title 21, Code of Federal Regulations, Section 530.3(a) (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 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 a (b)(4) to a bob veal calf identified with Sales tag #(b)(4) without following the withdrawal period as directed by your veterinarian. Your extralabel use of (b)(4) was not under supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of (b)(4) 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 C.F.R. 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).
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.
FDA acknowledges the written response we received from you in response to our inspection. Your letter dated September 1, 2013 states your firm has addressed the observations made during the recent inspection conducted on August 19 - 29, 2013 to prevent future violations. However, those specific actions were not identified, and an implementation date was not provided. Without supporting documentation, the effectiveness of your corrective measures cannot be determined.
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 Kristen Jackson, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433. If you have any questions about this letter, please contact Compliance Officer Kristen Jackson at (718) 662-5711 or email at email@example.com
Ronald M. Pace
New York District
cc: Mr. Everett Harold Day, Co-Owner
2999 Cooley Road
Canandaigua, NY 14424
cc: Dr. David Smith, Director
Division of Animal Industry
New York State Department of Agriculture & Markets
10 B Airline Drive
Albany, New York 12235