Inspections, Compliance, Enforcement, and Criminal Investigations
Caruso Cattle Company, Inc. 4/23/12
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New York District
158-15 Liberty Avenue
Jamaica, NY 11433
April 23, 2012
WARNING LETTER NYK-2012-16
VIA UNITED PARCEL SERVICE
Mr. Frank Caruso, President
Caruso Cattle Company, Inc.
205 Jackson Road
Frankfort, New York 13340-4372
Dear Mr. Caruso:
On March 1 and 9, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your livestock dealership located at 205 Jackson Road, Frankfort, New York 13340-4372. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C 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 FD&C 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 FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C 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 19, 2011, you sold a bull, identified with back tag# (b)(4), for slaughter as food. On or about December 20, 2011, (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 on December 20, 2011, identified the presence of 5.62 parts per million (ppm) of desfuroylceftiofur (marker residue) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the target tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113 (21 C.F.R. 556.113). The presence of this drug in edible tissue from this animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C 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 adequate treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4).
We also found that you adulterated the new animal drug (b)(4) (ceftiofur sodium sterile powder, NADA (b)(4)). Specifically, our investigation revealed that you did not use Naxcel as directed by its approved or prescribed 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 FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C 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 (b)(4) (ceftiofur sodium sterile powder, NADA (b)(4)) to your bull identified with back tag (b)(4) without following the withdrawal period in the prescribed or approved labeling. Your extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a) and your extralabel use grams resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was 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 FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C 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 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 may wish to consider the following guidance to avoid future illegal residue violations: 1. Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal; 2. Implementing a system to determine from the source of the animal whether the animal has been medicated and with what drug(s); and 3, If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.
You should be aware that it is not necessary for you to have personally shipped an animal in interstate commerce to be responsible for a violation of the FD&C Act. The fact that you offered an animal for sale to a slaughterhouse that ships in interstate commerce is sufficient to hold you responsible for a violation of the FDA&C Act.
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 Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any question's about this letter, please contact Compliance Officer Dean Rugnetta at (716) 541-0324 or Email at email@example.com.
Ronald M. Pace
New York District