Inspections, Compliance, Enforcement, and Criminal Investigations
Szarek, Francis J., 9/9/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New York District|
158-15 Liberty Avenue
Jamaica, NY 11433
September 9, 2009
WARNING LETTER NYK 2009-18
VIA FEDERAL EXPRESS
Francis J. Szarek, Owner
4797 Station Hill Road
Westmoreland, New York 13490-1119
Dear Mr. Szarek:
On April 8 and 10,2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your veal growing operation located at 4797 Station Hill Road, Westmoreland, New York. 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 December 11, 2008, you sold to (b)(4) a veal calf, identified with ear tag (b)(4) for slaughter as food. On or about December 12, 2008, (b)(4) located in (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 0.134 parts per million (ppm) of flunixin in the liver tissue. FDA has not established a tolerance for residues of flunixin in the edible tissues of veal calves. 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. 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 accurate 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).
We also found that you adulterated the new animal drugs Flunixin Meglumine and Lincomycin-Spectinomycin. Specifically, our investigation revealed that you did not use Flunixin Meglumine and Lincomycin-Spectinomycin as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. 21 C.F.R. 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered the drug Flunixin Meglumine intramuscularly instead of following your veterinarian's prescribed route of administration. In addition, you administered both Flunixin Meglumine and Lincomycin-Spectinomycin in a class of animal (veal calf) not set forth in the approved labeling and you did so without following the extralabel use directions of a licensed veterinarian, in violation of 21 CFR 530.11 (a). Furthermore, your extralabel use of Flunixin Meglumine resulted in an illegal residue, in violation of 21 CFR 530.11(c). Because your extralabel use of the drugs Flunixin Meglumine and Lincomycin-Spectinomycin was not in compliance with 21 CFR Part 530, these drugs were unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and your use caused them to be adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5).
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 are 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, 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 Dean Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl St, Suite 100, Buffalo, NY 14202. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at 716-541-0324, or email@example.com.
Camille D. Monde
Acting District Director
New York District
Cc: NY State Board of Veterinary Medicine (redacted)
89 Washington Avenue
Albany, NY 12234
Cc: Dr. John P. Huntley, Director (redacted)
Division of Animal Industry
New York State Department of Agriculture & Markets
10 B Airline Drive
Albany, NY 12235
Cc: Dr. Isabel Arrington (redacted)
USDA-FSIS, Technical Service Center
Edward Zorinsky Federal Building, Suite 260
1616 Capitol Avenue
Omaha, NE 68102-5908