Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100FAX: (612) 334-4142
August 8, 2014
Via UPS Overnight Delivery
Refer to MIN 14 - 22
Dennis J. Loppnow
Patti K. Loppnow
W1555 Northside Drive
Oconomowoc, Wisconsin 53066
Dear Mr. and Mrs. Loppnow:
On February 13 and March 10, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your veal operation located at W1555 Northside Drive, Oconomowoc, Wisconsin. 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 operations. 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 September 20, 2013, you sold a lot of (b)(4) veal calves, which included the calf identified with retain tag (b)(4), to (b)(4), for slaughter as food. On or about September 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 neomycin at 10.92 parts per million (ppm) in the kidney tissue.
FDA has established a tolerance of 7.2 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 CFR 556.430(b)(1). However, this tolerance does not apply to the use of (b)(4) (neomycin sulfate soluble powder, ANADA (b)(4)) in veal calves because the drug is not approved for use in veal calves. The presence of this drug in edible kidney tissue from this animal 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 and your contract facilities failed to maintain complete treatment records for animals that you medicate, and you lack an adequate system to identify individually medicated calves to ensure that withdrawal times have been observed prior to offering animals for slaughter for human food. 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 drugs (b)(4) (neomycin sulfate soluble powder, ANADA (b)(4)), (b)(4) (chlortetracycline hydrochloride soluble powder, ANADA (b)(4)) and the new human drug Sulfamethoxazole and Trimethoprim Tablets (SMZ-TMP), NDC (b)(4). Specifically, our investigation revealed that you did not use (b)(4), (b)(4), or SMZ-TMP as directed by their approved labeling or according to the directions for extralabel use prescribed by your veterinarian. Use of these drugs in this manner is an extralabel use. See 21 CFR 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 512(a)(5) of the FD&C Act, 21 U.S.C. §§ 360b(a)(4) and (5), and 21 CFR 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 contract veal barn, under your supervision, administered (b)(4) and SMZ-TMP without following the dose and duration of treatment as stated in the approved labeling or according to the directions for extralabel use prescribed by your veterinarian. Your extralabel use of these drugs was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use of (b)(4), (b)(4), or SMZ-TMP was in or on feed, in violation of 21 CFR 530.11(b), and your extralabel use of (b)(4) resulted in an illegal drug residue, in violation of 21 CFR 530.11(c). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 CFR Part 530, you caused these drugs 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 animal feed within the meaning of section 501(a)(6), 21 U.S.C. § 351(a)(6), when you added (b)(4), SMZ-TMP, and (b)(4), to milk replacer (a food/feed). The addition of these drugs to milk replacer caused that animal feed to be unsafe under section 512(a)(2) of the Act, 21 U.S.C. § 360b(a)(2), and adulterated within the meaning of section 501(a)(6) of the Act, 21 U.S.C. § 351(a)(6). Section 512 of the FD&C Act, 21 U.S.C. § 360b, and 21 CFR 530.11(b) do not permit the extralabel use of medicated feeds.
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 are 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 received your March 24, 2014, response to the Form FDA 483 issued at the close of the inspection on March 10, 2014. You stated that you are working with (b)(4) regarding the extralabel prescriptions and withdrawal times, that you received an updated protocol from (b)(4) for each of your growers, and that you are visiting with your contract growers to inform them of the protocols and to remind them to keep medication records for calves medicated individually and as a group. We cannot evaluate the adequacy of your proposed corrective action because you did not submit documentation with your response.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 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 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 Dr. Brian D. Garthwaite, Compliance Officer, U.S. Food and Drug Administration, at the address listed on this letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.
Michael Dutcher, DVM