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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Shirk, Clarence W, 17-Jul-08

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

Public Health Service
Food and Drug Administration

 

PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390


Warning Letter
08-PHI-12

July 17, 2008

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Clarence W. Shirk
353 Berry Lane
Beavertown, Pennsylvania 17813-9281

Dear Mr. Shirk:

On April 17, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 353 Berry Lane, Beavertown, Pennsylvania. 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 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. § 360b]. 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 August 14, 2007, you sold a bob veal calf, identified with back tag [redacted] for slaughter as food. On or about August 15, 2007, [redacted] 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 [redacted] at [redacted] parts per million (ppm) in the kidney tissue. FDA has not established a tolerance for residues of [redacted] in veal calves. The presence of [redacted] in edible tissues 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)].

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)].

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 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 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 James C. Illuminati, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania, 19106. If you have any questions about this letter, please contact Mr. James C. Illuminati at (215)717-3078 or via e-mail at james.illuminati@fda.hhs.gov.

Sincerely,

/S/

Thomas D. Gardine
District Director
Philadelphia District