| Public Health Service Food and Drug Administration |
New York District 158-15 Liberty Avenue Jamaica, NY 11433 |
Department of Health and Human Services
May 6, 2011
WARNING LETTER NYK-2011-20
VIA United Parcel Services
Inez Mattison, Majority Owner
Heritage Hill Farm
1582 Mattison Road
Fort Ann, New York 12827
Dear Ms. Mattison:
On March 10, 11 and 14, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1582 Mattison Road, Fort Ann, 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 November 15, 2010, you sold a bob veal calf, identified with ear tag (b)(4), for slaughter as food. On or about November 16, 2010, (b)(4) located in (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 at 0.193 parts per million (ppm) in the liver tissue and 0.213 ppm in the muscle tissue, and the presence of gentamicin in the kidney. FDA has not established tolerances for residues of sulfamethoxazole or gentamicin in bob veal calves. The presence of these drugs in the edible tissue from this animal in these amounts 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 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 drugs (b)(4), (gentamicin sulfate) and (b)(4). Specifically, our investigation revealed that you did not use (b)(4), and (b)(4), as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. See Title 21, Code of Federal Regulations (C.F.R.), 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 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 human drug (b)(4) to a bull calf without following the dose, frequency of treatment, and withdrawal period as stated in their approved labeling or any written directions by a licensed veterinarian. Our investigation also found that you administered the drug (b)(4) to a bull calf without following the withdrawal period as stated in its approved labeling or any written directions by a licensed veterinarian. Your extralabel use of (b)(4) and (b)(4) were 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) and (b)(4) resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(c). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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).
We acknowledge your letter dated March 19, 2011, in which you respond to the Form FDA 483 Inspectional Observations issued to you on March 14, 2011. Your letter is inadequate to provide corrective actions to all of the violations listed below because you have not provided any evidence to show that you have implemented the corrective actions promised in your letter.
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 Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean R. Rugnetta at (716) 541-0324 or Email at Dean.Rugnetta@fda.hhs.gov.
Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District
cc:
Roblee Mattison
1582 Mattison Road
Fort Ann, New York 12827
Travis Mattison
1582 Mattison Road
Fort Ann, New York 12827
Dr. David Smith, Director
Division of Animal Industry
New York State Department of Agriculture & Markets
10 B Airline Drive
Albany, New York 12235
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