| Public Health Service Food and Drug Administration |
PHILADELPHIA DISTRICT 900 U.S. Customhouse |
Department of Health and Human ServicesWARNING LETTER
10-PHI-11
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
August 30, 2010
Keith A. Reddick, Owner
Reddick Dairy
2705 Sandy Lake Grove City Road
Stoneboro, Pennsylvania 16153
Dear Mr. Reddick:
On March 23 - 24, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2705 Sandy Lake Grove City Road, Stoneboro, 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 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 17, 2009, you consigned a bob veal calf, identified with sales tag (b)(4) for slaughter as food. On or about August 18, 2009, (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 flunixin residues of (b)(4) parts per million (ppm) in the liver, and ppm in the muscle. Flunixin is not approved for use in calves to be processed for veal. The presence of this drug 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 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. Your records did not include the drug used, the dosage amount, the route of administration, and withdrawal times. 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 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 Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, U.S. Customhouse, Room 900, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Compliance Officer Robin M. Rivers at 215-717-3076 or via e-mail at Robin.Rivers@FDA.HHS.GOV.
Sincerely,
/S/
Kirk D. Sooter
District Director
Philadelphia District Office
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