Walk, Ed 1/23/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Chicago District|
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
January 23, 2013
Via UPS Next Day
Edward A. Walk, Owner
Ed Walk Farm
130 County Rd. 1200 N.
Neoga, IL 62447
Dear Mr. Walk:
On November 15, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your hog farrowing operation located at 130 County Rd., 1200 N., Neoga, Illinois. 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 the 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. 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 (b)(4), you sold (b)(4) swine animals, to (b)(4) for slaughter as food one of which was found to have residues of nafcillin and penicillin in its tissues. The violative sow was identified with (b)(4) number (b)(4). You identified your sale records from (b)(4), for this violative sow, as being a (b)(4) number (b)(4) and (b)(4) numbered (b)(4) all dated (b)(4). (b)(4) shipped all of these animals to (b)(4). On (b)(4) the United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) tested one sow (b)(4) and found violative residues of nafcillin and penicillin in its kidney. FDA has established a zero tolerance level for nafcillin and a zero tolerance level for residues of penicillin in the uncooked edible tissue of swine as codified Title 21, Code of Federal Regulations (C.F.R.) Part 556.510. The presence of these drugs in edible tissue from this animal in these amounts 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 and a drug inventory system.
The above is not intended to be an all-conclusive list of violations. As a producer of animal offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute are in compliance with the law.
You should take prompt action to correct the violations described in this letter and to establish procedure 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 in 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 Matthew Sienko, Compliance Officer, at the address of the letterhead. If you have any questions about this letter, please contact Mr. Sienko at 312-596-4213 or via e-mail 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
Office of Policy, Programs and Employee Development
1299 Farnam Street, Suite 300
Omaha, Nebraska 68102
Attention: Residue Staff