Inspections, Compliance, Enforcement, and Criminal Investigations
Western Illinois Grain Co. 13-Jul-06
Department of Health and Human Services
Public Health Service
July 13, 2006
RETURN RECEIPT REQUESTED
Mr. Chester J. Claudon, Owner
Mr. Russell E. Weaver, Owner
Western Illinois Grain Co.
14525 North 1150th'Road
Macomb, IL 61455
Dear Messrs. Claudon and Weaver:
An inspection conducted by the Food and Drug Administration of your medicated feed mill located at 1220 Carter Street, Fairview, Illinois, on April 10 and 11, 2006, found that your firm caused the new animal drug chlortetracycline to be unsafe within the meaning of Section 512 [21 U.S.C. § 360(b)] of the Federal Food, Drug, and Cosmetic Act (the Act) and adulterated within the meaning of Section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. In addition, your firm caused the new animal drug chlortetracycline to be misbranded within the meaning of Section 502(o) [21 U.S.C. § 352(o)] of the Act. The inspection also found significant deviations from the current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds, Title 21, Code of Federal Regulations (CFR), Part 225. Such deviations cause the feeds being manufactured at this facility to be adulterated within the meaning of Section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)] of the Act. You can find the Act and its associated regulations on the internet through links on FDA's web page at www.fda.gov.
Our inspection revealed that your firm purchases intact bags of the new animal drug chlortetracycline (specifically, [redacted] and, [redacted] a Category I, Type A medicated article, and then repackages the contents of the original bags into smaller portions, which are subsequently sold to several of your customers. This repackaging operation establishes your firm as a producer of a new animal drug, subject to the requirements of Section 510 [21 U.S.C. § 360] of the Act.
Establishments manufacturing Type A medicated articles are required to register annually as drug establishments and must submit a list of every drug in commercial distribution. Such establishments are subject to biennial inspection under Section 510 [21 U.S.C.§ 360] of the Act. In addition, an approved FD-356V, New Animal Drug Application(NADA), is required for the manufacture of a Type A medicated article containing a new animal drug, unless exempted under 21 CFR 558.15. A review of our records shows that your veterinary drug repackaging establishment, located at 1220 Carter Street, Fairview, Illinois 61432, is not registered and has not drug listed with the Food and Drug Administration. In addition, your firm purchased, received, and sold the new animal drug chlortetracycline in a manner that does not conform to an approved New Animal Drug Application (NADA) in accordance with Section 512 [21 U.S.C. § 360(b)] of the Act.
Because the new animal drug chlortetracycline is not covered by an approved NADA, as required by Section 512(a)(1)(A) [21 U.S.C. § 360(b)(1)(A)] of the Act, the drug is unsafe under Section 512(a) [21 U.S.C. § 360b(a)], and thus is adulterated pursuant to Section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. In addition, all drugs manufactured, prepared, propagated, compounded, or processed by your firm are misbranded within the meaning of Section 502(o) of the Act [21 U.S.C. § 352(o)] because your firm is not registered and/or has not drug listed as required by Section 510 of the Act.
We also wish to advise you that the container labeling on the repackaged portions of Type A medicated articles that your firm distributes must conform to the approved labeling contained in an approved NADA to comply with Section 512(a)(1)(A) [21 U.S.C. § 360b(a)(1)(A)] of the Act.
In addition, our inspection found the following significant current Good Manufacturing Practice violations, which cause the feeds being manufactured at this facility to be adulterated within the meaning of Section 501(a)(2)(B) [21 U.S.C. § 351(a)(2xB)] of the Act:
Failure to maintain procedures for the identification, storage, and inventory control (receipt and use) of all Type A medicated articles and Type B medicated feeds intended for use in the manufacture of medicated feeds to aid in assuring the identity, strength, quality, and purity of these drug sources [21 CFR 225.142].
Failure to maintain buildings and grounds in a manner that minimizes vermin and pest infestation [21 CFR 225.120].
The above is not intended as an all-inclusive list of violations. As a manufacturer of medicated and non-medicated feeds, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law.
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 regulatory and/or administrative sanctions without further notice. These sanctions include, but are not limited to, seizure and/or injunction. In addition, because of the observed cGMP deviations, we have notified the Center for Veterinary Medicine not to approve any New Animal Drug Applications that you may submit for approval consideration until you have corrected the violations.
You should notify this office, in writing, within 15 working days of receiving this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step 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 date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Your reply should be directed to Patrick J. Brown, Compliance Officer, at the address given in the letterhead.
Scott J. MacIntire