Inspections, Compliance, Enforcement, and Criminal Investigations
Grove River Mills Inc. 30-Jan-2003
Department of Health and Human Services
Public Health Service
Atlanta District Office
January 30, 2003
VIA FEDERAL EXPRESS
David L. Lathem
Grove River Mills Inc.
326 Jackson Concourse
Dear Mr. Lathem:
An inspection of your feed mill was conducted by a Food and Drug Administration (FDA) investigator between December 6, 2002 and January 15, 2003. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations (21 CFR), Part 589.2000 - Animal Proteins Prohibited, in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy(BSE). The deviations came the feed being manufactured and distributed by your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).
Animal feeds and feed ingredients containing any mammalian derived protein (prohibited material), such as bovine meat and bone meal, are considered potentially injurious to ruminant and public health. Therefore, the use of such materials in ruminant feed causes the feed to be adulterated under Section 402(a)(4) of the Act. Our inspection revealed that your firm manufactures feed for cattle, that may contain residues of prohibited material. The cattle feed is mixed in the same equipment that is used for mixing chicken feed containing bovine meat and bone meal.
You have failed to use clean-out procedures or other means adequate to prevent carry-over of protein derived frozen mammalian tissue to animal protein or feeds that may be used for ruminants, 21 CFR 589.2000(e)(1)(iii)(A) and (B). Specifically no clean-out procedures are performed on common receiving equipment or finished product storage bins used for prohibited and non-prohibited materials. The clean-out procedure utilized on delivery trucks failed to clean [redacted] truck compartments used to transport ruminant feeds containing prohibited material.
You have failed to maintain written clean-out procedures to prevent carry-over of protein derived from mammalian tissues to animal protein or feeds that may be used for ruminants, 21 CFR 589.2000(e)(1)(iv). Your firm does not have any written clean-out procedures for receiving equipment or finished product storage bins used for both ruminant and non-ruminant feeds.
Our investigator also found significant deviations from Current Good Manufacturing Practice (CGMP)regulations for Medicated Feeds (21 CFR Part 225). Such deviations cause feeds being manufactured at your facility to be adulterated within the meaning of section 501(a)(2)(B) of the Act.
You have failed to perform periodic assays during the calendar year on at least three representative samples of medicated feed requiring a medicated feed mill license, for each drug or drug combination used as required by 21 CFR 225.58(b)(l). You have sampled only one lot of medicated feed containing Amprolium 25% and Neomycin Oxytetracycline over the last year.
You have failed to establish a Master Record File which includes the complete procedure for manufacturing each specific product, setting forth the formulation, theoretical yield, manufacturing procedures, assay requirements, and labeling of batches or production runs as required by 21 CFR 225.102(a). The manufacturing instructions for each medicated feed were not included in the Master Record File, but were reportedly stored in the firm's computer system responsible for manufacturing feed.
You have failed to prepare original production records or copies there of by qualified personnel for each batch of medicated feed as required by 21 CFR 225.102(b)(2). A review of the production records generated from 6/14/02 through 12/06/02 did not include a complete history for each batch manufactured. The computer system in use required that batch records for a production run only be printed if a deviation occurred during the production of the batch. These records also did not require a written endorsement by a responsible individual to verify that the feed were properly manufactured.
The daily drug inventory records failed to include the batches or production runs of medicated feed in which each drug was used as required by 21 CPR 225.42(b)(6). Your drug receipt records failed to indicate the date of receipt, condition of the drug when received, and return of any damaged drugs for each lot of drug received, as required by 21 CFR 225.42(b)(5).
You have failed to establish and use adequate procedures for all equipment used in the production and distribution of medicated feeds to avoid unsafe contamination of medicated and non-medicated feeds as required by 21 CPR 225.165. No clean-out procedures have been established and no clean-out is required for common finished product storage bins and delivery trucks used for medicated and non-medicated feeds.
At the conclusion of the inspection the Inspectional Observations, FDA 483, was issued to and discussed with you. Neither the FDA 483 nor the above is intended as an all-inclusive list of violations at your firm. 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. We have included a copy of the FDA Guidance for Industry 68 - Small Entities Compliance Guide - Protein Blenders, Feed Manufacturers, and Distributors. We cannot stress )enough the seriousness of these deficiencies, and the importance of your firm being in complete compliance with the BSE regulations in regard to the mixing of ruminant feed. Your firm must adhere to the regulations to assure a safe ruminant feed and meat supply, or establish complete and separate receiving, mixing, handling, and feeding conveyances and equipment for ensuring such safety.
You should take prompt action to correct the above CGMP and BSE 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. 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) of the Act and 21 CFR 515.22(e)(2). This letter constitutes official notification under the law. Based on the results of the above 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 the receipt of 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 and BSE violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and 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 Philip S. Campbell, Compliance Officer, at the address noted in the letterhead.
Mary A. Woleske, Director