Inspections, Compliance, Enforcement, and Criminal Investigations
Peco Foods Inc 03-Jul-06
Department of Health and Human Services
Public Health Service
New Orleans District
July 3, 2006
WARNING LETTER NO. 2006-NOL-11
Mark A. Hickman, President
Peco Foods, Inc.
1020 Lurleen Wallace Boulevard
Tuscaloosa, Alabama 35403
Dear Mr. Hickman:
On March 14, 16, and 21, 2006, a United States Food and Drug Administration (FDA) investigator inspected your licensed medicated and non-medicated animal feed firm, located at 999 Herman Alford Memorial Highway, Philadelphia, Mississippi. Our investigator documented significant deviations from the Current Good Manufacturing Practice (CGMP) requirements for Medicated Feeds set forth in Title 21, Code of Federal Regulations, Part 225 (21 CFR 225). Such deviations cause the medicated feeds manufactured at your facility to be adulterated within the meaning of Section 501(a)(2)(B) [21 United States Code (USC) 351(a)(2)(B)] of the Federal Food, Drug, and Cosmetic Act (the Act). You may find the Act and its associated regulations through links at FDA's home page at www.fda.gov.
Observations documented include:
1. Failure to conduct potency assays on at least three representative samples of each medicated feed at periodic intervals during the calendar years 2004 and 2005 [21 CFR 225 .58(b)(1)] and,
2. Failure to document investigative and corrective actions when medicated feeds failed assay specifications [21 CFR 225 .58(d)].
A copy of the Form FDA 483 is enclosed.
The above violations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure your facility is operating in compliance with the Act and its implementing regulations.
You should take prompt action to correct these violations, and you should establish a system whereby such violations do not recur. Failure to promptly correct these CGMP violations may result in regulatory and/or administrative sanctions. The 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 USC 360b(m)(4)(B)(ii)] of the Act and 21 CFR 515.22(c)(2). This letter constitutes official notification under the law.
Based on the results of the inspection, 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 cited deficiencies.
You should notify this office in writing, within fifteen (15) working days of receiving this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence of similar violations . You should include in your response documentation, such as procedures, or other useful information to assist us in evaluating your corrections and/or copies of any available documentation demonstrating corrections made. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Your response should be directed to the U.S. Food and Drug Administration, Attention: Rebecca A. Asente, Compliance Officer, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding this letter, please contact Ms. Asente at (504) 219-8818, extension 104.
Carol S . Sanchez
Acting District Director
New Orleans District