John and Nicole Santos Dairy 12/20/12
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 Department of Health and Human Services
| Public Health Service
Food and Drug Administration |
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San Francisco District
Pacific Region
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510-337-6700
FAX: 510-337-6701
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UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Our Reference: 3005341755
WARNING LETTER
December 20, 2012
Joao (John) A. Santos, Owner
John and Nicole Santos Dairy
671 Hagerman Peak Drive
Newman, California 95360
Dear Mr. Santos:
On October 10, 11, 12, and 16, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 6119 Central Avenue, Turlock, 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 animals for slaughter as food that were 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 July 5, 2012, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about July 5, 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 sulfamethoxazole at 1.551 parts per million (ppm) in the liver and 2.898 ppm in the muscle tissue. On or about July 16, 2012, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about July 16, 2012, (b)(4) slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of sulfamethoxazole at 2.71 ppm in the liver and 10.124 ppm in the muscle tissue. FDA has not established a tolerance for residues of sulfamethoxazole in the edible tissues of calves intended for slaughter for veal. The presence of this drug in edible tissue from this animal 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 human drug Sulfamethoxazole and Trimethoprim tablets, (b)(4) (Penicillin G Procaine) (b)(4) (Oxytetracycline Hydrochloride Injection) (b)(4) (Ceftiofur (b)(4) and (b)(4)(Pirlimycin Hydrochloride Sterile Solution) (b)(4). Specifically, our investigation revealed that you did not use sulfamethoxazole/trimethoprim, penicillin G procaine, oxytetracycline, ceftiofur, and pirlimycin as directed by their approved labeling. Use of these drugs in this manner is an extralabel use; see 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 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 sulfamethoxazole/trimethoprim tablets to two of your veal (bull) calves identified with back tags (b)(4) without following the route of administration or withdrawal period as prescribed by your veterinarian. Your extralabel use of sulfamethoxazole/trimethoprim tablets was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a); your extralabel use of sulfamethoxazole/trimethoprim tablets was in or on an animal feed, in violation of 21 C.F.R. 530.11(b); and your extralabel use of sulfamethoxazole/trimethoprim tablets resulted in illegal residues, in violation of 21 C.F.R. 530.11(c).
Our investigation found that you routinely administered penicillin G procaine injectable suspension to your dairy cows without following the indications for use, dosage, or withdrawal period as stated in the approved labeling. Your extralabel use of penicillin G procaine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).
Our investigation found that you routinely administered oxytetracycline to your lactating dairy cows without following the indications, animal class, or withdrawal period as stated in the approved labeling. Your extralabel use of oxytetracycline was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).
Our investigation found that you routinely administered ceftiofur to your lactating dairy cows without following the withdrawal time as stated in the approved labeling. Your extralabel use of ceftiofur was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).
Our investigation found that you routinely administered pirlimycin to your lactating dairy cows without following the meat withhold period as stated in the approved labeling. Your extralabel use of pirlimycin 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, 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).
In addition, you adulterated sulfamethoxazole and trimethoprim within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. 351(a)(6), when you fed milk containing sulfamethoxazole/trimethoprim tablets to your calves. Your feeding of sulfamethoxazole in this manner caused the animal feed to be unsafe within the meaning of section 512 of the FD&C Act, 21 U.S.C. 360b. Section 512 of the FD&C Act, 21 U.S.C. 360b and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feeds.
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 are 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