Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/riverside-dairy-llc-06102015
Timestamp: 2020-07-08 08:44:19
Document Index: 376032420

Matched Legal Cases: ['§ 342', '§ 360', '§ 342', '§ 342', '§ 342', 'art 530', '§ 360', '§ 351']

Riverside Dairy, LLC - 06/10/2015 | FDA
Riverside Dairy, LLC - 06/10/2015
Riverside Dairy, LLC June 10, 2015
WARNING LETTER NYK-2015-37
Mr. Dale Van Erden, Co-Owner
Mr. Joel Rielhman, Co-Owner
2258 Lower Cincinnatus Road
Dear Messrs. Van Erden and Rielhman:
On April 9 and 20, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2258 Lower Cincinnatus Road, Cincinnatus, 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 two animals 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 February 3, 2015, you sold two bob veal calves, identified with New York State (NYS) Metal Ear Tag (b)(4)/Ear Tag (b)(4) and NYS Metal Ear Tag (b)(4)/Ear Tag (b)(4) respectively, for slaughter as food. On or about February 3, 2015, (b)(4), slaughtered these animals. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from these animals identified the presence of 14.52 parts per million (ppm) of neomycin in the kidney and 8.0 parts per million (ppm) of neomycin in the kidney respectively. FDA has established a tolerance of 7.2 parts per million (ppm) for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.430(b)(1) (21 C.F.R. 556.430(b)(1)). However, this tolerance does not apply to the use of (b)(4) containing neomycin sulfate and oxytetracycline hydrochloride in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of #(b)(4) containing neomycin sulfate and oxytetracycline hydrochloride in veal calves (pre-ruminating calves). Therefore, the presence of this drug in kidney tissue from these animals in these amounts cause 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 treatment records for calves medicated and identify and segregate treated animals. 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) (neomycin sulfate and oxytetracycline hydrochloride). 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 extra-label use. See 21 C.F.R. 530.3(a).
Our investigation found that your administered (b)(4) to two bob veal calves identified with NYS Metal Ear Tag (b)(4)/Ear Tag (b)(4) and NYS Metal Ear Tag (b)(4)/Ear Tag (b)(4) respectively without following the animal class as stated in the approved labeling. Your extra-label use of (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). In addition, your extra-label use of (b)(4) was in or on feed, in violation of 21 C.F.R. 530.11(b) and resulted in illegal residues, in violation of 21 C.F.R. 530.11(c). Because your use of this drug was not in conformance with the approved labeling and did not comply with 21 CFR 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).
cc: Mr. Robert G.W. Eichorst