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Public Health Service |
Denver District Office |
November 24, 2008
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Jose L. Gonzalez
Co-Owner
Gonzalez Dairy, LLC
14310 Stern Drive
Mesquite, NM 88048
Ref. #: DEN-09-02
Dear Mr. Gonzalez:
On September 9-11, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 14310 Stern Drive, Mesquite, New Mexico. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the 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 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 Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the 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 3, 2008, you sold a Holstein cow, identified with ear tag [(b)(4)] for slaughter as food. On or about July 5, 2008, [(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 identifed the presence of 10.19 ppm of Sulfamethazine in the liver (USDA Case No. 08-0481-NM). FDA has established a tolerance of 0.1 ppm for residues of Sulfamethazine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.670 (21 C.F.R. § 556.670). 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 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 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. You failed to review the treatment records for Holstein cow, ear tag [(b)(4)] prior to offering the animal for slaughter for human food to assure that the appropriate withdrawal times had been observed. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).
We also found that you adulterated the new animal drug Sulfamethazine. Specifically, our investigation revealed that you did not use Sulfamethazine as directed by its approved labeling. Use of this drug in this manner is an extralabel use. 21 C.F.R. § 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. § 360b(a)(4) and (5), and21 C.F.R. § 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 Sulfamethazine to Holstein cow with ear tag [(b)(4)] without following the dose and withdrawal times as stated in the approved labeling. Specifically, you administered three 32.1 gram boluses of [(b)(4)] per day for three consecutive days although the drug label indicated that a 1,000 pound cow should receive no more than five boluses within a 72 hour period. Also, the label states, "WARNING: Animals intended for human consumption should not be slaughtered for food for at least 12 days after the last dose. Exceeding two consecutive doses may cause violative tissue residiies to remain beyond the withdrawal time." Your extralabel use of Sulfamethazine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a), and your extralabel use of Sulfamethazine resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(c) and (d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. § 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the 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 above violations 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 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, state the reason for the delay and the time framewithin 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 William H. Sherer, Compliance Officer, U.S. Food and Drug Administration, P.O. Box 25087, Denver, Colorado, 80225-0087. If you have any questions about this letter, please contact Compliance Officer William S. Sherer at (303) 236-3051 or William.Sherer@fda.hhs.gov.
Sincerely yours,
/S/
H. Thomas Warwick
District Director
Denver District
cc: Ronald C. Nelson, D.V.M.
Denver District Director
USDA/FSIS
PO Box 25387
DFC, Bldg 45
Denver, CO 80225
Tel: 303-236-9800 Ex 69812
I. Miley Gonzalez, Ph.D.
Secretary
New Mexico Department of Agriculture
New Mexico State University
P.O. Box 300005, MSC 3189
Las Cruces, NM 88003-8005
Lee C. Jan, D .V.M.
Director
Texas Department of Health
Meat Safety Assurance Unit
1100 West 49th Street
Austin, TX 78756-7466
Department
of Health and Human Services