Inspections, Compliance, Enforcement, and Criminal Investigations
Archer Daniels Midland Company 19-Oct-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|Kansas City District |
11630 W. 80th Street
Lenexa, Kansas 66214
October 19, 2005
RETURN RECEIPT REQUESTED
Ref. KAN 2006-01
G. Allen Andreas, Chairman and Chief Executive
Archer Daniels Midland Company (ADM)
4666 Faries Parkway
P.O. Box 1470
Decatur, Illinois 62526
Dear Mr. Andreas:
An investigation of your medicated feed mill, registration number 1921796, located at 1210 W. 24th Terrace, Higginsville, Missouri conducted by a Food and Drug Administration (FDA) investigator on May 10th, 12th, 16th, 18th, 19th and June 1, 2005 found significant deviations from the 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) [21 U.S.C. §351(a)(2)(B)] of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found :
1. A failure to perform assays on representative samples of medicated feeds requiring a medicated feed mill license. For example, your firm failed to perform at least nine assays on medicated feeds in 2003 and at least eight separate medicated feed assays in 2004 [21 CFR 225.58(b)(1)].
2. Your drug inventory records do not accurately reflect your current inventory. For example, it was discovered and documented that a drug listed in your inventory was in fact no longer in the mill. There is no documentation as to what happened to the drug in your records [21 CFR 225.42(b)(6)(ii)].
3. You store drugs in the mixing area but do not properly identify, store, handle and control the drugs to maintain their integrity and identity. For example, when the contents of a bag was poured into a plastic tote, the bag with the lot identification and drug potency information was discarded [21 CFR 225.42(b)(4)].
Our investigator also noted that as of the time of the inspection, your medicated feed mill had not performed any, assays on medicated feeds yet this calendar year. Please keep in mind that you must collect and assay at least three representative samples of medicated feed containing each drug or drug combination in the establishment by approved methods at periodic intervals during 2005.
We also noted instances of whiteout used on official records, poor sanitation practices and label issues. Regarding the label issue, it is noted that a product was shipped to a customer with a label that identified the product as being manufactured by [redacted] at least a year after the mill became ADM We understand the computerized labeling system should address this problem, however we would like that perception substantiated in your reply.
The above is not intended as an all-inclusive list of cGMP violations . As a manufacturer of medicated feeds you are responsible for assuring your overall operation and the products you manufacture and distribute are in compliance with the Act and implementing regulations.
You should take prompt action to correct these cGMP violations. Failure to effect prompt and permanent corrective actions may result in regulatory and/or administrative sanctions including seizure, injunction and 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) of the Act [21 U.S.C. § 360b(m)(4)(B)(ii)] and 21 CFR 515.22(c)(2).
Based on the results of the inspection, evaluated together with the evidence before FDA when the Medicated Feed 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 drug therein. This letter constitutes official notification under the law and provides you an opportunity to correct the deficiencies in your operations.
You should notify this office in fifteen (15) working days of the steps you have taken to achieve and maintain compliance with the regulations. Please send your response to Ralph J. Gray, Compliance Officer, at the above address.
John W. Thorsky
Kansas City District