Inspections, Compliance, Enforcement, and Criminal Investigations

Vansridge Dairy 12/30/15

  

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 

 

December 30, 2015
 
 
WARNING LETTER NYK-2016-16
 
 
VIA UNITED POSTAL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. William W. Van Norstrand, Owner
Vansridge Dairy
2831 Black Street
Scipio Center, New York 13147-3173
 
Dear Mr. Van Norstrand:
 
On October 6 and 13, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation, Vansridge Dairy, located at 2831 Black Street, Scipio Center, New York 13147-3173. 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 August 25, 2015, you sold a dairy cow identified with (b)(4), for slaughter as food. On or about August 26, 2015, (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 0.058 parts per million (ppm) of penicillin in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (CFR), 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 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 Pro-Pen-G Injectable Suspension (penicillin G procaine, NADA #065-505). Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling and/or by a veterinarian’s prescription. 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 Pro-Pen-G Injectable Suspension (penicillin G procaine, NADA #065-505) to a dairy cow identified with (b)(4), without following the dosing instructions stated in the approved drug labeling. Your extralabel use of the Pro-Pen-G Injectable Suspension was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and your extralabel use of the Pro-Pen-G Injectable Suspension 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. 
 
We acknowledge your written response, dated October 14, 2015, to the Form FDA 483 that was issued to you at the close of the inspection on October 13, 2015. Your response acknowledged the violations and promised corrective actions.  These included the implementation of new protocols for cattle treated with penicillin in addition to the re-training of key employees. However, there is concern the new protocol would not address the potential cause for additional future residues. It is unclear if the “25 cc’s, twice a day” clause in the protocol would take into account the live weight of the animal to be treated. In addition, without a submission of treatment records to review for completeness, we cannot verify these corrective actions for effectiveness at this 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 CDR Frank Verni, 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 CDR Frank Verni at (718) 662-5702 or by e-mail at frank.verni@fda.hhs.gov.
 
Sincerely yours,
/S/
Ronald M. Pace         
District Director
New York District
 
cc:       
Mr. Aaron W. Van Norstrand, Partner
Vansridge Dairy
2831 Black Street
Scipio Center, New York 13147-3173

 

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