Jennie-O Turkey Store 27-Nov-02

this corrected version of the November 27, 2002, Warning letter was issued February 25, 2003, to correct an error in the original

November 27, 2002
CORRECTTED WARNING LETTER

Certified Mail
RETURN RECEIPT REQUESTED Refer to MIN 03 - 07

Jerry Jerome
Chief Executive Officer and Chairman of the Board
Jennie-O Turkey Store
2505 Willmar Avenue SW
Willmar, Minnesota 56201

Dearr Mr. Jerome:

On June 6, 2002, investigators from the Wisconsin Dcpartrncnt of Agriculture, Trade, and Consumer Protection, acting on behalf of the Food and Drug Administration, conducted an inspection of your medicated feed mill located at 64 North Ninth Street, Barron, Wisconsin 54812. That inspection found significant violalions of the Federal, Food, Drug, and Cosmetic Act (the Act) and deviations from Current Good Manufacturing Practices (CGMP) regulations as required by Title 21, Code of Federal Regulations (21 CFR).

The inspection found that the use of animal drugs in your feed (sulfadimethoxine, ormetoprim, chlortetracycline, diclazuril and bacitracin methylene disalicylate, monensin, and virginiamycin) does not conform to an approved New Animal Drug Application (NADA) as rquireded by Section 512 of the Act. For this reason, the drugs are unsafe under Section 512 of the Act and thus are adulterated under Section 501 (a)(5) of the Act.

The animal feed products noted below are also adulterated within the meaning of Section 501(a)(6) of the Act because they bear or contain new animal drugs but do not corform with an approved NADA. The feeds are thus unsafe under Section 512 of the Act and adultcrated under Section 501(a)(6) of the Act.

TURKEY FEED WITH [redacted] (chlortetracycline) -- The drug level in the feed is lnlxdcd as contcaining 200 g/ton, but the Product is labeled with indications for Use (treatment of bluecomb) that correspond to a drug level of 25 mg/lb of bodyweight. See 21 CFR 558.128(d)(1)(v) and (xiii), copy enclosed.

TURKEY FEED WITH [redacted] (diclazuril and bacitracin methylene disalicytate) - Labeling lacks a rcquircd statement “Not for use in
hens producing eggs for human consumption." See 21 CFR 558.198(d)(2), copy enlclosed.

TURKEY FEED WITH [redacted] (sulfadimethoxine and ormetoprim) -- Labeling lacks a required statement to “Withdraw 5 days before slaughter.” See 21 CFR 558.575(d)(3)(iii), copy enclosed.

TURKEY FEED WITH [redacted] (monensin and virginiamycin) -- The labeling lacks a portion of a required caution statement, specifically, "Some strains of turkey coccidia may be Monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis." See 21 CFR 558.355(f)(2)(iv)

The missing labeling statements also cause the TURKEY FEED WITH [redacted] (diclazuril and bacitracin methylene disalicylate), TURKEY FEED WITH [redacted] (sulfadimethoxine and ormetoprim) and TURKEY FEED WITH [redacted] (monensin and virginiamycin) animal feed products to be misbranded within the meaning of Section 502(c) of the Act.

The four animal feed products are also adulterated within the meaning of Section 501(a)(2)(B) of the Act for failing to comply with CGMP regulations with regard to the labeling requirements as articulated by 21 CFR 225.80(b)(2) and the record retention requirements as articulated by 21 CFR 225.102(b)(2).

Title 21, Code of Federal Regulations 225.80 (b)(2) requires proofread labels to be dated, initiated by a responsible individual, and kept for one year after all the labels from the batch have been used. Your failure to keep these labels for one year as required by the regulation rcndcrs the products adulterated under Section 501(a)(2)(B) of the Act.

The State investigators noted that the firm’s computer system generates a paper production record that provides a complete traceable history of the manufacturing process for each of tho medicated feed products it manufactures. The State investigators noted that the paper production records are discarded after 90 days. Feed Mill Manager William Carroll stated that the records are discarded due to the
significant amount of space they take up.

Title 21, Code Federal Regulation 225.102(b)(2) requires that the original production record or copy thereof shall be retained on premises for not less than one your. Because your firm has not adhered to ihis requirement, the manufactured products are adulterated within the meaning of Section 501(a)(2)(B) of the Act.

The above is not intended to be an all-inclusive list of violations, As a manufactures of animal feeds, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the Iaw.

You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to promptly correct these violations may result in further regulatory and/or administrative sanctions. These sanctions could include seizure, injunction, and/or notice of opportstnity for a hearing on a proposal to withdraw approval of your firm’s medicated feedl license under Section 512(m)(4)(B)(ii) of the Act and 21 CFR 514.115(c)(2). This Ietter constitutes official notification under the law, This Ietter notifies you of our findings and provides you an opportunity to correct the deficiencies.

You should notily this office in writing within 15 working days of tic steps you have taken to bring your firm into compliance with the law. Your response should include each step being taken, 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, state the reason for the delay and the time frame within which the corrections will bc completed. Please include copies of any available documentation demonstrating that corrections have been made. Your reply should
be addressed to Compliance Officer Timothy G. Philips at the address on the letterhead.

Sincerely,
/s/

David R. Yost
Acting Director
Minneapolis District