Inspections, Compliance, Enforcement, and Criminal Investigations
John Mellott Farm 12-Nov-08
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
November 12, 2008
John M. Mellott, Owner
John Mellott Farm
6512 Lemar Road
Mercersburg, PA 17236-9556
Dear Mr. Mellott:
On August 26 through 27, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 6512 Lemar Road, Mercersburg, 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. § 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 February 14, 2008, you sold a bob veal calf, identified with back tag [(b)(4)] for slaughter as food. On or about February 15, 2008, [(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 8.42 parts per million (ppm) neomycin in the kidney of this animal. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430(b)(1). The presence of neomycin in this amount in the kidney 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 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 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 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, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, PA 19106. If you have any questions regarding this letter, please contact Compliance Officer, Robin M. Rivers at 215-717-3076 or via e-mail at Robin.Rivers@FDA.HHS.GOV.
Thomas D. Gardine
Philadelphia District Office
Enclosure: FDA-483 dated August 26 - 27, 2008