Inspections, Compliance, Enforcement, and Criminal Investigations
Lloyd T. Smith & Sons 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 2009-19
VIA FEDERAL EXPRESS
Peter C. Smith, Partner
John D. Smith, Partner
Lloyd T. Smith & Sons
7071 County Route 27
Canton, New York 13617
Dear Messrs. Smith:
On June 16, 19, and 24, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 7071 County Route 27, Canton, 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 March 16, 2009, you sold a dairy cow identified with back tag (b)(4) farm tag (b)(4) for slaughter. On or about March 17, 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 0.14 parts per million (ppm) of penicillin residue in the kidney tissue. FDA has established a tolerance for residues of penicillin in the uncooked edible tissues of cattle at 0.05 ppm as codified in Title 21, Code of Federal Regulations, Section 556.510(a) (21 C.F.R. 556.510(a)). The presence of this drug in edible tissue 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).
We also found that you adulterated the new animal drug (b)(4) Penicillin G Procaine Injectable Solution (b)(4). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 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 in March 2009 you administered (b)(4) Penicillin G Procaine to a dairy cow, identified with back tag (b)(4) without following the indications, dosing instructions, and duration of treatment as stated in the drug's approved labeling. Additionally, our investigation found that in November 2008 you administered (b)(4) Penicillin G Procaine to a dairy cow, identified with back tag (b)(4)/ear tag (b)(4), without following the indications and dosing instructions as stated in the drug's approved labeling. Your extralabel uses of penicillin G procaine were not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use of penicillin G procaine in the dairy cow identified by back tag (b)(4)/farm tag (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel uses of this drug were not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and 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 these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
Our investigation also revealed that on or about October 2, 2008, you provided (b)(4) with a signed livestock owner's certification stating that none of the livestock shipped to or delivered to will have an illegal level of drug residues. This signed livestock owner's certificate covered the cow identified with back tag (b)(4)/farm tag (b)(4), which was found to contain a violative penicillin residue. Providing such a false guaranty is prohibited by section 301(h) of the Act, 21 U.S.C. 331(h). You should take appropriate actions to ensure that this violation does not recur.
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 directed to Dean Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Rugnetta at 716-541-0342; email
Camille D. Monde
Acting District Director
New York District
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