Inspections, Compliance, Enforcement, and Criminal Investigations
Madera Calf Ranch 22-Mar-07
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL EXPRESS
Our Reference: 3005562448
March 22, 2007
Michael W. Copeland, Owner
Madera Calf Ranch
M & T Farms
13894 Road 19 1/2
Madera, California 93637
Dear Mr. Copeland:
An inspection of your calf raising operation located at 13894 Road 19 1/2, Madera, California, conducted by a representative of the U.S. Food & Drug Administration (FDA) on October 27 and November 2, 2006 and subsequent collection of supporting documentation on January 19, 2007, revealed that you caused The new animal drugs gentamicin sulfate, penicillin G procaine, tylosin, and ceftiofur hydrochloride to become unsafe within the meaning of section 512 [21 U.S.C. § 360b] of the Federal Food, Drug, and Cosmetic Act (the Act) and adulterated within the meaning of section 5Ol (a)(5) [21 U.S.C. § 351 (a)(5)] of the Act. In addition, you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply causing food from these animals to be adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342 (a)(4)] of the Act. You can find the Act and its associated regulations on the internet through links on the FDA's web page at www.fda.gov.
Our inspection of your facility was part of a follow up investigation to an illegal drug residue reported by the United States Department of Agriculture, Food Safety Inspection Service (USDA/FSIS). On or about January 24, 2006, USDA/FSIS analysis of tissue samples collected from an animal raised at your facility as a calf, identified the presence of gentamicin, amount not quantified, in the kidney of this animal (USDA sample [redacted]). There is no tolerance level for gentamicin in the tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.300 (21 C.F.R. § 556.300).
Our inspection found that 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 any treatment records for the calves on your farm, instead relying on a generic letter sent to all of your customers indicating their animals "may" have been treated with drugs at your facility at the time of any illness. This letter does not list all the drugs you use on your farm and not all animals are treated with the drugs listed. You also lack an adequate inventory system for determining the quantities of drugs used to medicate the animals in your care. In addition, you are feeding milk from medicated dairy cows without knowing what drug residues and their amounts are in the milk. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Act.
In addition, you adulterated the drugs gentamicin sulfate ([redacted]), penicillin G procaine [redacted], tylosin [redacted] and ceftiofur hydrochloride [redacted] within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act 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) [21 U.S.C. § 360b(a)(4)] and 512(a)(5)[21 U.S.C. § 360b(a)(5)] of the Act and 21 C.F.R Part 530. Your extralabel use of these drugs failed to comply with these requirements.
For example, you administered gentamicin sulfate to the calves in your care without following your veterinarian's labeled directions to keep good records and identify treated calves, in violation of 21 C.F.R. 530.10(a).
Furthermore, our inspection revealed you administered penicillin to calves without following the dosage and indications for use as 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).
We also found during our inspection that you used the drug tylosin to treat pneumonia in the calves in your care without following the proper dosage as set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, also in violation of 21 C.F.R. 530.11(a).
Finally, our inspection found that you used the drug ceftiofier hydrochloride without following your veterinarian's written instructions for indications and frequency (i.e. [redacted]). Your extralabel use of ceftiofur hydrochloride failed to comply with the conditions for use and the dosage administration set forth in your veterinarian's instructions, in violation of 21 C.F.R. 530.10(a). Because your extralabel use of these drugs was not in compliance with 21 C.F.R. Part 530, these drugs are unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and your use caused them to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.
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 response should be directed to Karen L. Robles, Consumer Safety Officer, Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, please contact Karen Robles at (916) 930-3674, ext. 14.
Barbara J. Cassens
San Francisco District
encl: FDA-483 dated 2/6/06