Manuel Gaspar & Son Dairy 11/15/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Our Reference: 3009696154
November 15, 2012
Manuel A. Gaspar, Co-owner
Steve A. Gaspar, Co-owner
Filomena M. Gaspar, Co-owner
Manuel Gaspar & Son Dairy
7801 7 ½ Avenue
Hanford, California 93230
Dear Messrs Gaspar and Mrs. Gaspar:
On September 5 and 7, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 7801 7 ½ Avenue, Hanford, 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 May 10, 2012, you sold a bob veal (heifer) calf, identified with back tag (b)(4), for slaughter as food. On or about May 10, 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 neomycin at 19.58 parts per million (ppm) in the kidney and sulfamethoxazole at 1.487 ppm in the liver and 2.986 ppm in the muscle tissue. The FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, 556.430 (21 C.F.R. 556.430). However, this tolerance does not apply to use of (b)(4) (neomycin sulfate) in bob veal calves (pre-ruminating calves). FDA has not established a tolerance for residues of sulfamethoxazole in the edible tissues of veal calves. There is no acceptable level of residue associated with the use of these drugs in veal calves. The presence of these drugs in edible tissues from these animals in the amounts noted above 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 also found that you adulterated the new animal drug (b)(4) (neomycin sulfate) and the human drug Sulfamethoxazole and Trimethoprim (SMZ/TMP) Tablets, USP (b)(4). Specifically, our investigation revealed that you did not use (b)(4) and SMZ/TMP as directed by their approved labeling or veterinary prescription. Use of these drugs in this manner is an extralabel use, 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 (b)(4) and SMZ/TMP to one of your bob veal (heifer) calves identified with back tag (b)(4) without following the animal class or species, route of administration, or withdrawal periodas stated in the approved labeling or any directions by a licensed veterinarian. Your extralabel use of (b)(4) and SMZ/TMP was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of (b)(4) and SMZ/TMP was in or on feed, in violation of 21 C.F.R. 530.11(b) and your extralabel use of (b)(4) and SMZ/TMP resulted in illegal residues, in violation of 21 C.F.R. 530.11(c). 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).
In addition, you adulterated both (b)(4) and SMZ/TMP within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you fed the unapproved combination of the medicated feed and human drug to your bob veal calves. Your feeding of this unapproved combination in this manner and not as directed by the approved labeling caused this medicated 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 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
Barbara J. Cassens
San Francisco District
U. S. Food and Drug Administration