Inspections, Compliance, Enforcement, and Criminal Investigations
Four Brothers Dairy, Incorporated 16-Nov-05
Department of Health and Human Services
Public Health Service
November 16, 2005
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-15
Jerome Fitzgerald, President
Clement Fitzgerald, Vice President
Andrew W. Fitzgerald, Secretary-Treasurer
Four Brothers Dairy, Incorporated
425 North 250 West
Shoshone, ldaho 83352
Dear Messrs. Fitzgerald:
An investigation of your dairy operation located at 425 North 250 West, Shoshone, Idaho, conducted by a representative of the U.S. Food and Drug Administration (FDA) on September 21 and 26, 2005, confirmed that you offered an animal for sale for slaughter as food that was adulterated under section 402(a)(2)(C)(ii) [21 U.S.C. 342 § (a)(2)(C)(ii)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drug procaine penicillin G to become adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] and unsafe under section 512 of the Act [21 U.S.C. § 360b]. 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 January 24, 2005, you sold or delivered for sale a dairy cow, identified with Ear Tag #8219, for slaughtered as food to [redacted]. On or about January 26, 15, 2005, this animal was slaughtered at [redacted. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.09 parts per million (PPM) of penicillin in the kidney tissue. A tolerance of 0.05 PPM has been established for residues of penicillin in the 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 penicillin above the established tolerance level in edible tissues 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)].
In addition, you adulterated procaine penicillin G within the meaning of section 501(a)(5) of the Act [21 U.S.C. 351 (a)(5)] when you failed to use the drug in conformance with its 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 (a)(5)] and 21 C.F.R. Part 530. Our investigation found that your extralabel use of procaine penicillin G failed to comply with these requirements.
For example, you administered the procaine penicillin G without following the dosage level of treatment or the methods for injecting the drug set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). You also administered the procaine penicillin G without following the recommended withdrawal time for the drug set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, again in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because your extralabel use of this drug was not in compliance with 21 CFR Part 530, the drug was unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and your use caused it to be adulterated within the meaning of section 501(a)(5) of the 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 above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action, such as seizure and/or injunction, without further notice.
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.
Please send your written reply to the Food and Drug Administration, Attention : Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen