Inspections, Compliance, Enforcement, and Criminal Investigations
Country Morning Farms 15-May-08
Department of Health and Human Services
Public Health Service
May 15, 2008
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-14
Gerald L. Gilbert, President
Country Morning Farms
223 North Country Road
Warden, Washington 98857
Dear Mr. Gilbert:
An inspection of your dairy operation located at 650 North Fox Road, Warden, Washington, conducted by a representative of the U.S. Food and Drug Administration (FDA) on March 18-26, 2008, revealed that you caused the new animal drug sulfadimethoxine to become unsafe under section 512(a) of the Federal Food, Drug, and Cosmetic Act (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)]. 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 February 1, 2008, you consigned a dairy cow, identified with ear tag number [redacted] for slaughter as food. On or about February 1, 2008, 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 sulfadimethoxine in the liver tissue at 14.45 parts per million (ppm). Furthermore, on or about February 19, 2008, you consigned another dairy cow, identified with ear tag number [redacted] for slaughter as food. On or about February 19, 2008, this animal was slaughtered at [redacted] USDA/FSIS analysis of tissue samples collected from that animal identified the presence of sulfadimethoxine in the liver tissue at 5.81 ppm. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Part 556.640(b)(21 C.F.R. 556.640(b)).
Our investigation found that~you adulterated sulfadimethoxine within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] when you failed to use this 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 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 investigation found that your extralabel use of sulfadimethoxine failed to comply with these requirements.
For example, you administered a higher dosage of sulfadimethoxine (Albon) than indicated on the drug's approved label, and you did not observe the pre-slaughter withdrawal period required by the drug's approved label. The extralabel use of sulfadimethoxine is prohibited in lactating dairy cows by 21 C.F.R. 530.41(9). Furthermore, your extralabel use of sulfadimethoxine 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 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 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 Michael J. Donovan, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about this letter, please contact Mr: Michael Donovan at (425)483-4906.
Charles M. Breen