Inspections, Compliance, Enforcement, and Criminal Investigations
Alliance Dairies 28-May-08
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
May 28, 2008
Ronald P. St. John, Managing Partner
4951 NW 170th Street
Trenton, Florida 32693-7859
Dear Mr. St. John:
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 March 11-12, 2008, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) 121 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 penicillin and tylosin 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)]. Furthermore, the inspection 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 about January 26, 2008, you sold a dairy cow, identified with back tag [redacted] to [redacted]. This dairy cow was subsequently transported to [redacted] for slaughter as food on or about January 28, 2008. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of penicillin in the kidney tissue at 0.17 parts per million (ppm). A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.510 (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 inspection 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 the new animal drugs penicillin and tylosin 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 extralabel use complies 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, including that the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. Our inspection found that your extralabel use of penicillin and tylosin failed to comply with these requirements.
For example, you administered penicillin without following the dosage level, duration of treatment, frequency of treatment, and withdrawal period set forth in the approved labeling. In addition, you administered tylosin without following the approved conditions of use set forth in the approved labeling; tylosin is not approved for use in lactating dairy cattle. The above extralabel uses were done without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use of penicillin resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d).
Because your extralabel uses of these drugs were not in compliance with 21 C.F.R. Part 530, these 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)].
Finally, on January 26, 2008, your firm provided [redacted], hauler for [redacted] a signed certificate stating that the animals from your farm he was transporting for slaughter that day were "free of illegal amounts of antibiotic residues." However, the dairy cow with back tag [redacted] that you sold to [redacted] that day contained illegal levels of penicillin, an antibiotic. Providing such a false guaranty is a prohibited act under section 301(h) of the Act [21 U.S.C. § 331(h)].
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.
Emma R. Singleton
Director, Florida District