Inspections, Compliance, Enforcement, and Criminal Investigations
Glick, Jonathan J. 28-May-08
Department of Health and Human Services
Public Health Service
May 28, 2008
RETURN RECEIPT REQUESTED
Jonathan J. Glick, Owner
375 Zeigler Road
Howard, Pennsylvania 16841
Dear Mr. Glick:
An investigation of your dairy operation located at 375 Zeigler Road, Howard, Pennsylvania conducted by a representative of the U.S. Food and Drug Administration (FDA) on January-17, 2008, confirmed that you offered an .animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii)[21 U.S.C. §342(a)(2)(C)(ii)] and 402(a)(4)[21 U.S.C. §342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on-the Internet through links on the FDA's web page at www.fda.gov.
On or about September 6, 2007, you sold a cow, identified with back tag [redacted] and ear tag [redacted] for slaughter as food at [redacted]. On or about September 7, 2007, this animal was slaughtered at [redacted] United State Department of Agriculture, Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 3.05 parts per million (ppm) sulfadimethoxine in the liver tissue and 1.41 ppm sulfadimethoxine in the muscle tissue of the animal. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.640 (21 C.F.R. 556.640). The presence of this drug in the edible tissues of this animal at the reported levels 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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. 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 as 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, including 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, 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 Compliance Officer, James C. Illuminati, at 215-717-3078 or via e-mail at email@example.com.
Thomas D . Gardine
cc: Dr. David R. Griswold, Acting, Director
Pennsylvania Department of Agriculture
Bureau of Animal Health and Diagnostic Services (BAHDS)
2301 North Cameron Street
Harrisburg, Pennsylvania 17120
Office of Policy, Program & Employee Development
1299 Farnam Street
Omaha, NE 68102