|Subject:||Illegal Drug Residue|
|Issuer:||San Francisco District Office|
|Issued:||Feb. 1, 2008||Closed:||
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL EXPRESS
Our Reference: 1000522910
February 1, 2008
Fred Sherman, Co-owner
Scott K. Sherman, Co-owner
Trent Sherman, Co-owner
5600 West Palm Avenue
Winton, California 95388
Dear Messrs. Sherman:
An inspection of your dairy operation located at 5600 West Palm Avenue, Winton, California, conducted by a representative of the U.S. Food and Drug Administration (FDA) on November 2, 5, and 13, 2007, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. §342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. §342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drug AgriPharm PEN-AQUEOUS, Penicillin G Procaine, Injectable Suspension U.S.P. to become unsafe within the meaning of section 512(a) [21 U.S.C. §360b(a)] of the Act and adulterated within the meaning of section 501(a)(5) (21 U.S.C. §351(a)(5)] 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 .
On or about August 15, 2007, you consigned a dairy cow, identified by ear tag number [redacted] and back tag number [redacted] , for slaughter as food at [redacted] . United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected (USDA laboratory report number [redacted] ) from that animal identified the presence of penicillin in the kidney at 0.29 parts per million (ppm). 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 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) [21 U.S.C. §342(a)(2)(C)(ii)] of the Act.
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) [21 U.S.C. §342(a)(4)] of the Act.
In addition, you adulterated AgriPharm PEN-AQUEOUS, Penicillin G Procaine, Injectable Suspension U.S.P. within the meaning of section 501(a)(5) [21 U.S.C. §351(a)(5)] of the Act 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) [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.
Our investigation found that your extralabel use of AgriPharm PEN-AQUEOUS, Penicillin G Procaine, Injectable Suspension U.S.P. failed to comply with these requirements. For example, you administered AgriPharm PEN-AQUEOUS, Penicillin C Procaine, Injectable Suspension U.S.P. without following the dosage level 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). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of this drug was not in compliance with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) [21 U.S.C. §360b(a)] of the Act and your use caused it to be adulterated within the meaning of section 501 (a)(5) j21 U.S.C. §351 (a)(5)] of the 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 violations specified in this letter 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 specified 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 corrective actions have been made.
Your written response should be sent to, Karen L. Robles, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about this letter, please contact Ms. Karen Robles at (916) 930-3674, Ext. 114.
Barbara J. Cassens
San Francisco District