Inspections, Compliance, Enforcement, and Criminal Investigations
Carters Milk Factory 5/19/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Denver District Office|
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
May 19, 2009
RETURN RECEIPT REQUESTED
Alva Carter Jr. and Allen Carter, Co-Owners,
Carters Milk Factory
1263 S. Roosevelt Road P
Portales, NM 88130-6232
Ref: DEN-09-05 WL
Dear Messrs. Carter Jr, and Carter:
On January 21, 23, and 28, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1263 S. Roosevelt Road P, Portales, 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 011 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 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. §3C10b. 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 7, 2008, you sold a cow identified with back tag number (b)(4), for slaughter as food. On or about July 8, 2008, (b)(4) slaughtered this animal. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.379 parts per million (ppm) of flunixin in the liver and 0.90ppm of desfuroylceftiofur in the kidney. In addition; on or about August 13, 2008, you sold a dairy cow, identified with back tag number (b)(4), for slaughter as food. On or about August 14, 2008, (b)(4) slaughtered this animal. The USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 0.818 ppm of flunixin in the liver. FDA has established a tolerance of 0.125 ppm for residents of flunixin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.286 (21 C.F.R. 556.286). FDA has established a tolerance of 0.4 ppm for residues of desfuroylceftiofur in the edible tissues of cattle as codified in 21 C.F.R. 556.113. The presence of these drugs in edible tissues from this animal in these amounts 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 complete treatment records. 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 drugs (b)(4) (flunixin meglumine), and (b)(4) (ceftiofur sodium). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs 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), 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 in August 2008 you administered (b)(4) (flunixin meglumine), and (b)(4) (ceftiofur sodium) to a dairy cow, "identified with back tag number (b)(4), without following the withdrawal period as stated in the approved labeling, Because your use of these drugs were 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 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). In addition, your extralabel use of (b)(4) (flunixin meglumine) resulted in an illegal drug residue in this animal, in violation of 21 C.F.R." 530.11 (d).
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 Carolyn A. Pinney, Compliance Officer, U.S. Food and Drug Administration, 6th Ave & Kipling Street, Building 20, Denver, Colorado 80225. If you have any questions about this letter, please contact Compliance Officer Carolyn A. Pinney at (303) 236-3024; fax 303-236-3551; e-mail Carolyn.Pinney@fda.hhs.gov:
H. Thomas Warwick, Jr.
Denver District Director