| Public Health Service Food and Drug Administration |
San Francisco District |
Department of Health and Human ServicesUNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Our Reference: 3009054762
WARNING LETTER
October 27, 2011
Mr. Jose Joe L. Pimentel, Co-Owner
Mrs. Maria Z. Pimentel, Co-Owner
Joe L. Pimentel Dairy
21102 South Lammers Road
Tracy, California 95304
Dear Mr. & Mrs. Pimentel:
On September 2, 9, and 12, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 20246 South Lammers Road, Tracy, 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 26, 2011, you sold a dairy cow identified with back tag (b)(4), for slaughter as food. On or about May 28, 2011, (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 sulfadimethoxine at 0.41 parts per million (ppm) in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.640 (21 C.F.R. 556.640).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 also found that you adulterated the new animal drug sulfadimethoxine (b)(4). Specifically, our investigation revealed that you did not use sulfadimethoxine as directed by its approved labeling. Use of this drug 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 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 sulfadimethoxine (b)(4) to one of your dairy cows identified with back tag (b)(4) without following the dosage as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling, you caused the drug 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.
Our investigation also revealed that on or about May 26, 2011, you provided to (b)(4), a signed Bill of Sale or Consignment that states that the cows with tag (b)(4) and (b)(4) did not have an illegal level of drug residues. On or about May 26, 2011, you delivered a cow identified with tag (b)(4), which contained a violative sulfadimethoxine residue, to (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
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 Darlene Almogela, 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
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