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  5. C.R. Melear Corporation - 05/18/2015
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WARNING LETTER

C.R. Melear Corporation May 18, 2015

C.R. Melear Corporation - 05/18/2015

Product:
Animal & Veterinary

Recipient:
C.R. Melear Corporation


United States

Issuing Office:
Florida District Office

United States


   

Department of Health and Human Services logoDepartment of Health and Human Services

Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
Fax: 407-475-4770 

 

VIA USPS PRIORITY MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
FLA-15-24
May 18, 2015
 
Mr. Thomas S. Watkins, President
Mr. Thomas Carlton Watkins, General Manager
C.R. Melear Corporation
P.O. Box 1647
Avon Park, FL 33826
 
Dear Mr. Thomas Watkins and Mr. Thomas Carlton Watkins:
 
On April 8 and 9th, 2015, the Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 148 Barn 1 Rd, Zolfo Springs, 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 August 21, 2014, you sold a dairy cow identified with ear tag (b)(4) (back tag # (b)(4)) for slaughter as food.  On or about August 21, 2014, (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 0.111 parts per million (ppm) in the kidney tissue.  FDA has established a tolerance of 0.05 for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 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 VetriPen G (penicilllin G procaine, NADA 065-505). Specifically, our investigation revealed that you did not use VetriPen G injectable suspension as directed by its approved labeling.  Use of these drugs 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 VetriPen G to a dairy cow identified with ear tag #(b)(4)  (back tag #(b)(4)) without following the indications for use and duration of treatment as stated in the approved labeling. Your extralabel use of VetriPen G was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of VetriPen 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 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 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.
 
 
Sincerely,
/s/ 
Susan M. Turcovski
Director, Florida District

 

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