Inspections, Compliance, Enforcement, and Criminal Investigations
CHS, Incorporated 16-May-06
Department of Health and Human Services
Public Health Service
May 16, 2006
RETURN RECEIPT REQUESTED
John Johnson, President and CEO
5500 Cenex Drive
Invergrove Heights, MN 55077
In reply refer to Warning Letter SEA 06-30
Dear Mr. Johnson:
An investigation of your medicated feed mill located at 5325 10th Avenue North, Great Falls, Montana, conducted by a Food and Drug Administration investigator on March 2, 3, and 6, 2006, found significant deviations from Current Good Manufacturing Practice (CGMP) regulations for medicated feeds (Title 21, Code Of Federal Regulations, Part 225). Such deviations cause the medicated feeds 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 Federal Food, Drug, and Cosmetic Act.
Our investigation found your firm was not conducting 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 as required by 21 C.F.R. § 225.58(b)(1). Specifically, during the 2005 calendar year, your medicated feed mill manufactured [redacted] batches of medicated feed containing [redacted], a Category II, Type A medicated article with chlortetracycline and sulfamethazine, and [redacted] batches of medicated feed containing [redacted] a Category II, Type A medicated article with amprolium, without performing any of the required assays.
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 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 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 C.F.R.§ 515.22(c)(2). This letter constitutes official notification under the law.
Based on the results of the March 2006 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.
You should notify this office, in writing, within fifteen (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 being taken to correct the CGMP 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.
Please send your reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M . Breen