Inspections, Compliance, Enforcement, and Criminal Investigations
Harris Dairies 09-Jun-08
Department of Health and Human Services
Public Health Service
June 9, 2008
In reply refer to Warning Letter: 2008-DAL-WL-13
RETURN RECEIPT REQUESTED
Mr. Jerry-Harris, Owner
23220 County Road 441
Rising Star, Texas 76471
Dear Mr. Harris:
An inspection of your dairy operation located at the above address, conducted by a representative of the U.S. Food and Drug Administration (FDA) on March 17 - 19, 2008, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(2)(C)(ii) and 21 U.S.C. § 342(a)(4)]. The inspection also revealed that you caused the new animal drug, sulfadimethoxine soluble powder, to become 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)]. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On December 7, 2007, you sold a Holstein dairy cow, identified with Back Tag [(b)(4)] for slaughter as food to [(b)(4)]. On December 8, 2007, this animal was slaughtered at [(b)(4)] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of sulfadimethoxine at 0.13 part per million (ppm) in the liver tissue. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.640(b)(1) [21 C.F.R. 556.640(b)(1)]. The presence of this drug in this amount in edible tissue from this animal 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 inspection 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. You lack 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. For example, you failed to maintain complete treatment records, and you failed to assure that appropriate withdrawal times have 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)].
In addition, you adulterated [(b)(4)] (Brand of Sulfadimethoxine) Antibacterial Soluble Powder [(b)(4)] within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use complies with sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. § 360b(a)(4) and 21 U.S.C. § 360b(a)(5)] and 21 C.F.R. Part 530, including that the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of sulfadimethoxine is prohibited in lactating dairy cows under 21 C.F.R. 530.41(a)(9). Furthermore, your extralabel use 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 and did not comply with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and your use caused it to be adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)].
At the completion of the inspection a Form FDA 483, Inspectional Observations, describing deficiencies in your operations was issued to, and discussed with, Mr. Jerrel S. Harris, Manager of Harris Dairies. A copy of that document is attached for your information.
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 that 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 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, 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 James R. Lahar, Compliance Officer, U.S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204-3128. If you have any questions about this letter, please contact Mr. Lahar at (214) 253-5219.
Reynaldo R. Rodriguez, Jr.
Enclosure. Form FDA-483, Inspectional Observations, issued on 3/19/200$
cc: Mr. Jerrel S. Harris, Manager
23220 County Road 441
Rising Star, Texas 76471