- Animal & Veterinary
- El-Vi Farms, LLC
- Issuing Office:
- New York District Office
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
November 12, 2014
WARNING LETTER NYK-2015-6
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. George M. Andrew, Partner
Mr. Kim S. Skellie, Partner
Mr. Josh Peck, Partner
Mr. Ted Peck, Partner
Mr. Allan Ruffalo, Partner
El-Vi Farms, LLC
14 Pelis Road
Newark, New York 14513-8919
Dear Messrs. Andrew, Skellie, Peck, Peck and Ruffalo:
On September 2 and 5, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 14 Pelis Road, Newark, New York. 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 the 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 23, 2013, you sold a cow, identified with back tag (b)(4), and farm tag (b)(4), for slaughter as food. On or about December 24, 2013, (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 4.16 parts per million (ppm) of desfuroylceftiofur (marker residue for ceftiofur) in the kidney. FDA has established a tolerance of 0.4 parts per million (ppm) for residues of desfuroylceftiofur in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.113(b)(3)(i) (21 C.F.R. 556.113(b)(3)(i)). 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 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 complete 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 hydrochloride, ANADA (b)(4)). Specifically, our investigation revealed that you did not use (b)(4) 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 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) to a cow, identified with back tag (b)(4), and farm tag (b)(4) without following the dosage for use per injection site as stated in the approved label. Your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Certain uses of ceftiofur (e.g. unapproved doses) are prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(13)(ii). Because your use of this drug was not in conformance with the 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.
FDA acknowledges the written response dated September 26, 2014 that we received following our inspection. The letter states your farm has reviewed all treatment and drug use protocols to ensure a safe product is provided to the consumer. However, in view of the number of employees designated to administer medication, your response does not address any training or oversight in this regard. Further, your response to the record keeping deficiencies committed only to incorporating staff initials in these records. Therefore, the effectiveness of your corrective measures can only be determined over time.
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 Lillian C. Aveta, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Lillian C. Aveta at (718) 662-5576 or by e-mail at Lillian.Aveta@fda.hhs.gov
Ronald M. Pace
New York District