Inspections, Compliance, Enforcement, and Criminal Investigations
Hi Hills Farm 2/13/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
February 13, 2013
WARNING LETTER CIN-13-392470-13
VIA UNITED PARCEL SERVICE
Timothy A. Stitzlein, Owner
Hi Hills Farm
21500 Nashville Road (State Route 514)
Glenmont, Ohio 44628
Dear Mr. Stitzlein:
On December 17 and 19, 2012 and January 4, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 31553 Nashville Road (State Route 514) Glenmont, Ohio. 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 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 July 2, 2012, you sold a bob veal calf identified with back tag # (b)(4) for slaughter as food. On or about July 5, 2012, (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 46.82 parts per million (ppm) of neomycin in the kidney. 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, Section 556.430(b)(1) (21 C.F.R. 556.430(b)(1)). However, this tolerance does not apply to the use of IBA Scour Treat 10g 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 IBA Scour Treat 10g 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 the animals medicated and you failed to maintain an adequate inventory of drugs used to treat your 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 drug IBA Scour Treat 10g. Specifically, our investigation revealed that you did not use IBA Scour Treat 10g as directed by the approved labeling. Use of the drug in this manner is an extra-label use. 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 IBA Scour Treat 10g to a bob veal calf identified with back tag # (b)(4) without following the animal class as stated in the approved labeling. Your extra-label use of IBA Scour Treat 10g 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 IBA Scour Treat 10g was in or on feed, in violation of 21 C.F.R. 530.11(b) and resulted in and illegal residue, 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 IBA Scour Treat 10g 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.
Our investigation also revealed that on or about June 17, 2011, you provided to (b)(4) Auction, a signed certification that states that the livestock you sell do not have illegal levels of drug residues. According to the certificate, it remains in effect until the undersigned delivers written notice of revocation to the market. On or about July 2, 2012, you delivered a bob veal calf identified with back tag (b)(4) , which contained a violative neomycin residue, to (b)(4) Auction. Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.
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 Stephen J. Rabe, 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 Rabe at 513-679-2700, ext. 2163 or firstname.lastname@example.org.
Paul J. Teitell