Inspections, Compliance, Enforcement, and Criminal Investigations
Berne Hi Way Hatchery, Inc. 24-Nov-04
Department of Health and Human Services
Public Health Service
November 24, 2004
RETURN RECEIPT REQUESTED
Mr. Fred L. Bixler
Berne Hi Way Hatchery, Inc.
656 U.S. 27 North
Berne, Indiana 46711-0307
Dear Mr. Bixler:
An investigation of your medicated feed mill located at 656 US 27 North Berne, IN conducted by a Food and Drug Administration investigator on July 15-16, 2004 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 being 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 investigation found failure to 1) predetermine sequential production, as required by 21 CFR 225.65(b)(3); 2) label bulk medicated feed, as required by 21 CFR 225.80(b)(3); and 3) maintain complete master record files and production records that comply with the requirements of 21 CFR 225.102.
This is not intended as an all inclusive list of COMP violations. We understand that you thought that your operation was exempt from CGMP and labeling requirements because you own both the feed and animals at all locations. As our Investigator advised during his inspection of September 3, 2004, your operation is not exempt from the requirements of these regulations. We acknowledge receipt of, your September 3, 2004 request to withdraw our Medicated Feed License (MFL). Although by giving up your MFL you are removing your operation from the requirements the CGMP regulations specified by 21 CFR 225.10 to 225.115, we wish to remind you that your firm is still obligated to meet the CGMP regulations specified in 21 CFR 225.120 to 225.202.
In addition, non-ruminant feed that contains or may contain prohibited material must be accompanied by a label that bears the caution statement "Do Not Feed to Cattle or Other Ruminants." Because you do not label your bulk feed with this statement, the feed is misbranded within the meaning of section403(a)(1) of the Act. You have reportedly committed to effect correction by placing a placard listing the statement at each location feeding feed with prohibited material. Failure to promptly correct the violation may result in regulatory and/or administrative sanctions. These sanctions include but are not limited to, seizure and/or injunction.
You should notify this office in writing, within fifteen (15) working days of the receipt of this letter of the steps that you have taken to bring your firm into compliance with the law. Your response should include an explanation of the actual steps taken to correct the labeling violation. If corrective action cannot be completed within 30 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 the corrections have been made.
Your response should be directed to Judith A. Putz, Compliance Officer at the above address.
Joann M. Givens