December 3, 2013
WARNING LETTER
CIN-14-412782-05
Via United Parcel Service
Mr. Trent Stoller, Co-Owner & Manager
Van Erk Dairy LLC
8789 State Route 114
Haviland, Ohio 45851
Dear Mr. Stoller:
On July 18 - 19, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8789 State Route 114, Haviland, Ohio 45851. 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 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 March 18, 2013, you sold a culled dairy cow, identified with ear tag (b)(4) and back tag (b)(4), for slaughter as food. On or about March 20, 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 desfuroylceftiofur, a marker residue for ceftiofur, at 1.2 parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.4 ppm for residues of ceftiofur in the kidney 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 tissues 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 systematically review treatment records prior to offering an animal for slaughter for human food to assure that drugs have been used only as directed and that appropriate withhold times have been observed. 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 Naxcel 4 grams Sterile Powder (Ceftiofur Sodium Sterile Powder, NADA #140-338). Specifically, our investigation revealed that you did not use Naxcel 4 grams Sterile Powder 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 Naxcel 4 grams Sterile Powder (Ceftiofur Sodium Sterile Powder, NADA #140-338) to a dairy cow identified with ear tag (b)(4) and back tag (b)(4) without following the withdrawal period as stated in the approved labeling. Your extralabel use of Naxcel 4 grams Sterile Powder was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of Naxcel 4 grams Sterile Powder 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 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 Mark E. Parmon, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Mark E. Parmon at (513) 679-2700, Ext. 2162 or email at Mark.Parmon@fda.hhs.gov.
Sincerely yours,
/S/
Marianne Allen
Acting District Director
Cincinnati District
Cc:
Mr. Tobin W. Hartzler, Co-Owner & Manager
Van Erk Dairy LLC
8789 State Route 114
Haviland, Ohio 45851
No comments:
Post a Comment