- Animal & Veterinary
- Graham Farms, Inc.
- Issuing Office:
- Florida District Office
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
February 19, 2015
Mr. Stu Wyllie
CEO, Graham Companies
6843 Main Street
Miami Lakes, Florida 33014
Dear Mr. Wyllie:
On January 13, 14, and 15, 2015, the Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 3144 Graham Dairy Road, Moore Haven, Florida. This letter notifies you of 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 July 17, 2014, you sold a dairy cow identified with back tag (b)(4) (ear tag #(b)(4)) for slaughter as food. On or about July 17, 2014, (b)(4), also known as (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 penicillin at 0.201 parts per million (ppm) in the kidney. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.510 (21 C.F.R. 556.510). 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. 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 drug Bactracillin G, (Penicillin G Procaine, NADA 065-010). Specifically, our investigation revealed that you did not use Bactracillin G injectable suspension as directed by its approved labeling or veterinary prescription. Use of this drug in this manner is an extralabel use. See 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 Bactracillin G to a dairy cow with back tab (b)(4) (ear tag #(b)(4)) without following the withdrawal time as stated in the approved label. Also, our investigation found that your extralabel use of Bactracillin G resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). 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).
We note your written response, received in our office on January 30, 2015, to the Form FDA 483 issued to your firm on January 15, 2015. All voluntary corrections indicated in your response will be verified at the next scheduled inspection of your farm.
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 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 timeframe 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 Carla Norris, Compliance Officer, at the address on this letterhead. If you have any questions about this letter, please contact Carla Norris at (407) 475-4730.
Susan M. Turcovski
Director, Florida District
Mr. Louis Babb Toms
Vice President, Graham Farms, Inc.
P.O. Box 1108
Moore Haven, FL 33471