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  5. Riverside Dairy, LLC - 06/10/2015
  1. Compliance Actions and Activities

WARNING LETTER

Riverside Dairy, LLC

Product:
Animal & Veterinary

Recipient:
Riverside Dairy, LLC


United States

Issuing Office:
New York District Office

United States


   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New York District 
158-15 Liberty Avenue 
Jamaica, NY 11433
(718) 340-7000

 

June 10, 2015
 
WARNING LETTER NYK-2015-37
 
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Dale Van Erden, Co-Owner
Mr. Joel Rielhman, Co-Owner
Riverside Dairy, LLC
2258 Lower Cincinnatus Road
Cincinnatus, New York 13040
 
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).
 
The extra-label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label 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 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). 
 
In addition, you adulterated (b)(4) medicated feed within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you failed to use the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Section 512 of the FD&C Act, 21 U.S.C. § 360b, and 21 C.F.R. 530.11(b) do not permit the extra-label use of medicated feed.
 
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 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.
 
Sincerely yours,
/S/ 
Ronald M. Pace
District Director
New York District
 
  
cc:       Mr. Robert G.W. Eichorst
            Manager
            Riverside Dairy, LLC
            2258 Lower Cincinnatus Road
            Cincinnatus, NY 13040