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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Modesto Junior College 10/1/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
San Francisco District
Pacific Region
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
 
Telephone:    510-337-6700
FAX:    510-337-6701

 

UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Our Reference: 3009091521
            WARNING LETTER
October 1, 2012
 
John A. Mendes, Animal Science Instructor
Mark Anglin, Dean of Agricultural Sciences
Modesto Junior College
435 College Avenue
Modesto, California 95350
 
Dear Messrs. Mendes and Anglin:
 
On July 31 and August 2, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your swine unit located at 2201 Blue Gum Avenue, Modesto, California.  This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov
 
We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.
 
Specifically, our investigation revealed that on or about February 3, 2012, you sold a sow identified with ear tag (b)(4) for slaughter as food.  On or about February 6, 2012, (b)(4) slaughtered this animal.  United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of penicillin in the muscle and kidney tissues. FDA has not established a tolerance for residues of penicillin in the uncooked edible tissue of swine. The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
 
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. 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 FD&C Act, 21 U.S.C. § 342(a)(4).
 
We found that you adulterated the new animal drugs penicillin G benzathine and penicillin G procaine (b)(4), oxytetracycline injection (b)(4), and ceftiofur sterile suspension (b)(4). Specifically, our investigation revealed that you did not use penicillin G benzathine and penicillin G procaine, oxytetracycline injection, and ceftiofur sterile suspension as directed by their approved labeling.  Use of these drugs in this manner is an extralabel use.  See Title 21, Code of Federal Regulations (C.F.R.), Section 530.3(a) (21 C.F.R. 530.3(a)). We have enclosed a copy for your reference.
 
The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. 
 
Our investigation found that you administered penicillin G benzathine and penicillin G procaine, to one of your sows identified with ear tag (b)(4), without following the animal class as stated in the approved labeling.  Your extralabel use of penicillin G benzathine and penicillin G procaine was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a), and your extralabel use of penicillin G benzathine and penicillin G procaine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c).
 
We found that you administered oxytetracycline injection, to your piglets without following the conditions for use as stated in the approved labeling. Your extralabel use of oxytetracycline injection was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).
 
We found that you administered ceftiofur sterile suspension to your piglets without following the conditions for use as stated in the approved labeling. Your extralabel use of ceftiofur sterile suspension was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).
 
Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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 violations described in this letter and to establish procedures to ensure that these 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 of receiving this letter, 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 Lawton W. Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, at 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 1114 or via e-mail at Karen.Robles@fda.hhs.gov.
 
Sincerely, 
/S/
Barbara J. Cassens
District Director
San Francisco District
U. S. Food and Drug Administration