| Public Health Service Food and Drug Administration |
New England District One Montvale Avenue |
Department of Health and Human Services
WARNING LETTER
CMS#245774
VIA OVERNIGHT UPS
November 30, 2011
Antonio Resendes
159 Basin Harbor Road
Bridgeport, Vermont 05734
Dear Mr. Resendes:
On October 14, October 18, and October 28, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 159 Basin Harbor Road, Bridgeport, Vermont. 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 June 16, 2011, you sold a calf identified with ear tag #(b)(4) for slaughter as food. On or about June 17, 2011, (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 0.055 parts per million (ppm) in the liver 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 tissues 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 drug treatment and drug inventory records. In addition, you lack an adequate system for assuring that expired drugs are discarded and not used. 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 drugs Sulfamethoxazole and Trimethoprim, (b)(4). Specifically, our investigation revealed that you did not use the sulfamethoxazole and trimethoprim product as directed by its approved labeling. Use of these drugs in this manner is an extralabel use, 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 sulfamethoxazole and trimethoprim to a bob veal calf without following the usage as stated in the approved labeling and or any directions by a licensed veterinarian. Your extralabel use of sulfamethoxazole and trimethoprim was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a) and resulted in an illegal residue, in violation of 21 C.F.R. 530.11 (c). Because your use of this drug was not in conformance with a licensed veterinarian's prescribed labeling and did not comply with 21 C.F.R. Part 530, 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.
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 Todd Maushart, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have any questions about this letter please contact Compliance Officer Todd Maushart at (781) 587-7486.
Sincerely,
/S/
Mutahar S. Shamsi
District Director
New England District
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