Inspections, Compliance, Enforcement, and Criminal Investigations
Furst McNess Company 19-Aug-05
Department of Health and Human Services
Public Health Service
Cincinnati District Office
August 19, 2005
Terry Gogel, Executive VP
Furst McNess Company
120 E. Clark St.
Freeport, IL 61032
Dear Mr. Gogel:
Inspections of your licensed medicated feed mill, McNess Livestock Nutrition, located at 1102 Fulton Road, Mayfield, KY 42066-2960, conducted by Food and Drug Administration investigators, on 3/23-24/2005 and 4/26-28/2005, found significant deviations from Current Good Manufacturing Practice (CGMP) regulations for Medicated Feeds (Title 21, Code of Federal Regulations, Part 225). Such deviations cause feeds 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).
Our inspections found deviations including, but not limited to the following:
1) Failure to investigate and implement corrective action when assay results show medicated feeds are outside permissible assay limits [21 CFR 225.58(d)].
Assay results for: (1) [redacted] feed, submitted 2/7/2005; and (2) [redacted] feed, dated 4/1/2005, show one or more failing results yet no investigation or corrective actions were documented.
You are also required to immediately report any drug assay failure of one or more batches of animal feed containing new animal drugs for which an approved medicated feed mill license is in effect [21 CFR 510.301(a)(2)]. Such failure should be reported to FDA, Center for Veterinary Medicine, Medicated Feeds Team (HFV-226), Room E431, 7519 Standish Place, Rockville, MD 20855.
2) Failure to have a daily inventory record that includes the quantity of each drug component on hand at the beginning and end of each work day [21 CFR 225.42(b)(6)(i)].
For example, the "Drug Storage Usage Chart" for [redacted] does not indicate a final weigh back on 3/10/05.
3) Failure to establish a Master Record File that provides the complete procedure for manufacturing a specific product and contains the complete manufacturing procedures ( including mixing steps and times), a copy or description of labeling, sampling instructions, assay requirements, and labeling of batches [21 CFR 225.102].
4) Failure to assure production records include the complete history of each batch of medicated feed including the following required information:
(a) actual quantity of drug component used [21 CFR 225.102(b)(2)(ii)];
(b) actual quantity of medicated feed used [21 CFR 225 .102(b)(2)(iv)]; and
(c) individual batch lot number or other identification that is applied to the label for each batch produced that will permit tracing of the complete batch history of the product [21 CFR 225.102(b)(5)].
When multiple batches are produced on the same day, you fail to maintain complete individual batch records that include the actual quantities of drugs weighed and added, individual batch labels and lot numbers, and actual final weights of each batch. Instead, a single batch record is prepared and individual batches and production quantities are recorded with a check mark.
5) Failure to review and check each batch record at the end of each day by a responsible person to determine whether all required production steps have' been performed and to initiate an investigation and document corrective actions if significant discrepancies are noted [21 CFR 225.102(b)(4)].
The above is not intended as an all-inclusive list of violations at your facility. 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 comply with the law.
You should take prompt action to correct these CGMP violations and establish procedures whereby such violations do not recur. Failure to promptly correct these CGMP violations may result in regulatory action without further notice to you. These actions 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(c)(2).
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.
Your response should be directed to Charles S. Price, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237-3097.
If you have any questions regarding this letter, you may call Mr. Price at (513) 679-2700, extension 165.
Carol A. Heppe