Inspections, Compliance, Enforcement, and Criminal Investigations
Bardstown Mill, Inc. 08-Apr-04
Department of Health and Human Services
Public Health Service
Cincinnati District Office
VIA FEDERAL EXPRESS
April 8, 2004
Mr. Thomas S. Hurst, Jr., Owner
Bardstown Mill, Inc.
204 W. Muir St
Bardstown, KY 40004
WARNING LETTER CIN-04-20830
On January 7,21-22, 2004, a Food and Drug Administration investigator conducted an inspection of your feed mill located at 204 W. Muir St., Bardstown, KY 40004. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE).
Our inspection found your firm failed to label feeds or mark the invoices of feeds that contain, or may contain, prohibited materials with the required cautionary statement “Do Not Feed To Cattle Or Other Ruminants”. We suggest this statement be distinguished by different type size or color or other means of highlighting the statement so it is easily noticed by the purchaser.
The deviations from the BSE regulations, as noted above, cause products being manufactured and distributed by your facility to be misbranded within the meaning of Section 403(a)(1) of the Federal Food Drug and Cosmetic Act (the Act).
This letter is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. We have enclosed a copy of the FDA’s Small Entity Compliance Guide to assist you with complying with the regulation. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice. Such actions include 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 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 Stephen J. Rabe, Compliance Officer at the address listed above.
Carol A. Heppe
Attachment: Small Entity Compliance Guide