Inspections, Compliance, Enforcement, and Criminal Investigations
Oak Grove Pork Inc 4/3/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
April 3, 2013
Via UPS Next Day
Kenneth E. Doyle, President
Oak Grove Pork Farm Inc.
12118 Spring Road
Gillespie, Illinois 62033
Dear Mr. Doyle:
On February 11 and 27, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your hog operation located at 12118 Spring Road, Gillespie, Illinois. This letter notifies you of the violation 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 September 24, 2012, you sold a sow to (b)(4). The sow was shipped directly from your facility to (b)(4) for slaughter as food. The sow was identified with bangle tag number (b)(4) and ear tag number (b)(4). On September 25, 2012 the United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) retained the sow with bangle tag (b)(4) and ear tag (b)(4), and gave a retain tag of (b)(4) to the sow. USDA took a surveillance sample and analysis revealed violative residues of penicillin in the kidney. FDA has established a zero tolerance level for residues of penicillin in the uncooked edible tissue of swine as codified Title 21, Code of Federal Regulations (CFR) Part 556.510. 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)]. Because you sold the adulterated food in interstate commerce, you violated Section 301(a) of the Act.
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 Norocillin (penicillin G procaine) NADA 065-010. Specifically, our investigation revealed that you did not use Norocillin 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).
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 Norocillin to a sow with bangle tag (b)(4) without following the dose as stated in the approved labeling. Your extralabel use of Norocillin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Norocillin resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). 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, 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 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 compliant 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 timeframe 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 directed to Rosemary Sexton, Compliance Officer, U.S. Food and Drug Administration, 550 W. Jackson Blvd., 15th Floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS case #394345 ). If you have any questions about the content of this letter, please contact Ms. Sexton at 312-596-4225 or via email at email@example.com.
Scott J. MacIntire
cc: Illinois Department of Agriculture
Bureau of Animal Health
State Fairgrounds – P.O. Box 19281
Springfield, Illinois 62794-9281
United States Department of Agriculture
Food Safety and Inspection Service
Attention: Residue Staff
Edward Zorinsky Federal Building
1616 Capitol Avenue, Suite 260
Omaha, NE 68102-5908