Inspections, Compliance, Enforcement, and Criminal Investigations
Milbank Mills Inc 22-Nov-05
Department of Health and Human Services
Public Health Service
Kansas City District
November 22, 2005
RETURN RECEIPT REQUESTED
Ref. KAN 2006-04
Mr. Edward P. Milbank, President
Milbank Mills, Inc.
P.O. Box 763
Chillicothe, Missouri 64601-0183
Dear Mr. Milbank:
An investigation of your medicated feed mill was conducted by a Food and Drug Administration investigator on June-7, 8 and July 6, 2005 and found significant deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds, Title 21 Code of Federal Regulations, Part 225 (21 CFR?225). Such deviations cause feeds being manufactured at this facility. to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 351(a)(2)(B)]
Our investigation found deviations including, but not limited to, the following:
Failure to consistently and adequately control the receipt, storage, and inventory of drug products. For instance:
• Failure to properly identify and control drugs in the mixing areas to maintain their integrity and identity. [21 CFR 225.42(b)(4)]
• Drug receipt records do not accurately indicate the identity, quantity, and condition of the drug.when received. [21 CFR 225.42(b)(5)]
• Failure to maintain an accurate daily inventory record for each drug used in the manufacture of medicated feeds. [21 CFR 225.42(b)(6)]
• Failure to investigate and take corrective action for a significant discrepancy between actual .drug usage and theoretical drug usage: [21 CFR 225.42(b)(7)]
Failure to conduct potency, assays on at least three representative samples of each feed required to be manufactured by a licensed medicated feed mill at periodic intervals during the calendar year. [21 CFR 225.58(b)(1)]
Failure to have batch production records checked by a responsible individual at the end of the working day to determine whether all required production steps have been performed. [21 CFR 225.102(b)(4)]
The above is not intended as an all-inclusive list of cGMP violations. As a manufacturer of medicated and non-medicated feeds, you are responsible for assuring 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 cGMP violations, and you should establish procedures whereby such violations do not recur. Failure to promptly correct these cGMP violations may result in regulatory and/or administrative sanctions. These sanctions include, but are not limited to, seizure, injunction, and/or notice of opportunity for a hearing on a proposal to withdraw, approval of your Medicated Feed Mill License under section 512(m)(4)(B)(ii) [21 U.S.C: 360b(m)(4)(B)(ii)] of the Act and 21 CFR 515.22(c)(2).
Based on the results of the June 7, 8 & July 6, 2005 inspection, evaluated together with the evidence before FDA when the Medicated Feed Mill License was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of medicated feeds are inadequate to assure and preserve the identity, strength, quality, and purity of the new animal drugs therein. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies.
Our office is in receipt of your letter dated July 12, 2005, submitted in response to the FDA 483 -Inspectional Observations issued to your firm on July 6, 2005. No evidence has been submitted to FDA to indicate your firm has identified the underlying cause(s) of the violations. Thus FDA cannot be assured your firm has implemented effective measures to prevent recurrence of the cited violations.
You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of any additional steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the cGMP violations and prevent their recurrence. If corrective action cannot be completed within 30 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 response should be directed to Nadine Nanko Johnson, Compliance Officer, at the above address.
John W. Thorsky
Kansas City District
Copy to: Tony L. Claxton, Feed and Seed Program Coordinator
Plant Industries Division
Bureau of Feed and Seed
Missouri Department of Agriculture
P.O. Box 630
Jefferson City, MO 65102