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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Valley View Pork 6/18/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Sutte 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139 

 

WARNING LETTER
2013-DET-19
June 18, 2013
 
VIA UPS
 
Fred H. Walcott, Member
Valley View Pork LLC
P.O. Box 158
Allendale, Michigan 49401
 
Mr. Walcott:
 
On April 15 and 17, 2013 and May 9, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your swine operation located at 5701 North Maple Island Road, Walkerville, Michigan 49720. This letter notifies you of the violations 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 18, 2012 you sold a sow identified with ear tag (b)(4)” and “(b)(4)”  ear tag “(b)(4)” for slaughter as food. On or about September 20, 2012 “(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 identified the presence of penicillin in the kidney and muscle.  FDA has not established a tolerance for residues of penicillin in the edible tissues of swine as codified in Title 21, Code of Federal Regulations, Section 556.510, 21 C.F.R. 556.510. The presence of this drug in edible tissues from this animal causes the food to be adulterated under 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. 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).
 
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. 
 
We acknowledge receipt of your May 21, 2013, letter in response to the Form FDA 483 Inspectional Observations issued to you at the close of the above inspection. Your response states that after working with your veterinarian you have updated the withholding table in your SOP to reflect an extended withdrawal period of 21 days for penicillin. You also explained that you have updated your treatment records to reflect the dosage, withdrawal time, and the name of the person who administered the drug. In addition, you state that you have reviewed these corrective actions with your employees. You provided our investigator with a copy of the updated withholding table before the close of the above inspection. However, we were unable to verify the other corrections identified in your response because no actual documentation of these corrections was provided. For example, your response did not include a copy of your new treatment records.   
 
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 Tina M. Pawlowski, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact Compliance Officer Pawlowski at (313) 393-8217 or by email at tina.pawlowski@fda.hhs.gov.
 
Sincerely yours,
/S/
Glenn T. Bass
District Director
Detroit District Office
 
 
Cc:  
Terry TenBrink, Member
Toby Sorenson, Member
Russell Walcott, Member
Valley View Pork LLC
P.O. Box 158
Allendale, Michigan 49401