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  5. Barrington Dairy Farm - 02/02/2015
  1. Compliance Actions and Activities

WARNING LETTER

Barrington Dairy Farm

Product:
Animal & Veterinary

Recipient:
Barrington Dairy Farm


United States

Issuing Office:
Florida District Office

United States


   

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

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

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-15-12
 
February 2, 2015
Mr. Joseph G. Barrington, Owner
Barrington Dairy
20567 168th Street
Live Oak, Florida 32060-5610
 
Dear Mr. Barrington:
 
On December 3, 4 and 5, 2014, the Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 20567 168th Street, Live Oak, 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 two animals for slaughter as food that were 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 March 15, 2014, you sold a dairy cow identified with back tag (b)(4) (ear tag (b)(4)) for slaughter as food.  On or about March 17, 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 desfuroylceftiofur (marker residue for ceftiofur) at 3.52 parts per million (ppm) in the kidney. Our investigation also revealed that on or about May 27, 2014, you sold a dairy cow identified with back tag (b)(4)(ear tag (b)(4)) for slaughter as food.  On or about May 28, 2014, (b)(4) slaughtered this animal.  USDA/FSIS analysis of tissue samples collected from this animal identified the presence of desfuroylceftiofur at 3.67 ppm in the kidney. FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113(b)(3)(i) (21 C.F.R. 556.113(b)(3)(i)). The presence of this drug in edible tissues from these animals 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 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 drugs Naxcel (Ceftiofur sodium, NADA 140-338) and Excenel RTU EZ (Ceftiofur hydrochloride, NADA 141-288). Specifically, our investigation revealed that you did not use Naxcel and Excenel RTU EZ as directed by their approved labeling or veterinary prescription.  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 Excenel RTU EZ to a dairy cow with back tag (b)(4) (ear tag (b)(4)) without following the indication for use as stated in the approved label. Also, our investigation found that you administered Naxcel to a dairy cow with back tag (b)(4) (ear tag (b)(4)) without following the specified route of administration and without following the indication for use as stated in the approved label. Your extralabel use of Excenel RTU EZ and Naxcel was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel use of Excenel RTU EZ and Naxcel resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d). Your extralabel use of cephalosporin (Excenel RTU EZ and Naxcel), by an unapproved route of administration and at unapproved doses, is prohibited by 21 C.F.R. § 530.41(13)(ii). 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 these 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).
 
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. 
 
Our investigation also revealed that on or about March 15, 2014, you signed the (b)(4) buyer/shipper document specifying that the dairy cow identified with back tag (b)(4) was free of illegal amounts of antibiotic residue. On or about March 15, 2014, you delivered a dairy cow identified with back tag (b)(4)(ear tag (b)(4)), which contained violative residues of desfuroylceftiofur, to (b)(4). Our investigation also revealed that on or about May 27, 2014, you signed the (b)(4) buyer/shipper document specifying that the dairy cow identified with back tag (b)(4) was free of illegal amounts of antibiotic residue. On or about May 27, 2014, you delivered a dairy cow identified with back tag (b)(4) (ear tag (b)(4)), which contained violative residues of desfuroylceftiofur, to (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
 
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.
 
Sincerely,
/S/
Susan M. Turcovski
Director, Florida District