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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Full Circle Dairy, LLC 02-Jul-08

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

Public Health Service
Food and Drug Administration

 

555 Winderley Place, Ste. 200
Maitland, Florida 32751

Telephone: (407) 475-4700
FAX: (407) 475-4769


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 

WARNING LETTER

FLA-08-22

July 2, 2008

Michael A. Blesy II
Chief Operating Officer
Full Circle Dairy, LLC
1479 S.E. Winquepin Street
Lee, Florida 32059

Dear Mr. Blesy:

An inspection of your dairy operation located at the above address, conducted by a representative of the U.S. Food and Drug Administration (FDA) on February 6 and 11, 2008, confirmed that you offered animals for sale for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(2)(C)(ii) and 21 U.S.C. § 342(a)(4)]. The inspection also revealed that you caused the new animal drugs, Flunixin Meglumine and Penicillin G Procaine, to become unsafe under section 512(a) of the Act [21 U.S.C. §360b(a)] and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. The investigation also revealed that you provided a false guaranty, a prohibited act under section 301(h) of the Act [21 U.S.C. 331(h)]. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

On or about August 7, 2007 you sold a dairy cow, identified with ear tag [redacted] to [redacted] This dairy cow was subsequently transported to [redacted] for slaughter as food on or about August 9, 2007. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of flunixin in the liver tissue at 0.236 parts per million (ppm). A tolerance of 0.125 ppm has been established for residues of flunixin in liver tissue of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.286. The presence of this drug in this amount in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act [(21 U.S.C. § 342(a)(2)(C)(ii)].
 

On or about June 2, 2007 you sold a dairy cow, identified with ear tag [redacted] to [redacted] This dairy cow was subsequently transported to [redacted] for slaughter as food on or about June 4, 2007. USDA/FSIS analysis of tissue samples collected from that animal identified the presence of penicillin in the kidney tissue at 0.11 ppm. A tolerance of 0.05 has been established for residues of penicillin in the edible tissues of a dairy cow as codified in 21 C.F.R. 556.510. The presence of this drug in this amount in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the 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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. 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 Act [21 U.S.C. § 342(a)(4)].

In addition, you adulterated Flunixin Meglumine and Penicillin G Procaine within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] when you failed to use these drugs in conformance with their approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. § 360b(a)(4) and 21 U.S.C. § 360b(a)(5)] and 21 C.F.R. Part 530. Our investigation found that your extralabel use of Flunixin Meglumine and Penicillin G Procaine failed to comply with these requirements.

For example, you administered the Flunixin Meglumine and Penicillin G Procaine without following the withdrawal periods set forth in the approved labeling for these products and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of these drugs were not in compliance with 21 C.F.R. Part 530, the drugs were unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and your use caused them to be adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)].

On or about June 2, 2007, you provided [redacted] with a signed certification, which states that you were not delivering to [redacted] any livestock having illegal levels of antibiotic residues. On or about June 2, 2007, you delivered a culled dairy cow containing high levels of violative penicillin residues to [redacted] Pursuant to section 301(h) of the Act [21 U.S.C. 331(h)], providing such a false guaranty is a prohibited act.

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 above violations and to establish procedures whereby such 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, 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 Brant M. Schroeder, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions about this letter, please contact Compliance Officer Schroeder at (407) 475-4763.

Sincerely,

/S/

Emma R. Singleton
District Director
Florida District

cc:
Dr. Marion F. Aller
Florida Department of Agriculture and Consumer Services
Division of Food Safety
3125 Conner Boulevard, Suite D
Tallahassee, Florida 32399-1650

Dr. Rex Holt, Director
Georgia Department of Agriculture
Animal Industry Division
19 MLK, Jr. Drive, Room 108
Atlanta, Georgia 30334

Dr. Julie Cornett
USDA-FSIS, Technical Service Center
Landmark Center, Suite 300
1299 Farnam Street
Omaha, Nebraska 68102

David P. Kelbert, D.V.M.
Chief Production Officer
Full Circle Dairy
P.O. Box 1359
St. Augustine, Florida 32085