Inspections, Compliance, Enforcement, and Criminal Investigations
The Hyland Co., Inc. 21-Aug-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
August 21, 2001
HAND DELIVERY REQUESTED
Barbara J. Hinton, President
The Hyland Co., Inc.
P.O. BOX 29
Ashland, KY 41105-0029
Dear Ms. Hinton:
From 7/24-27/2001 representatives from the Food and Drug Administration (FDA) and the State of Kentucky conducted an inspection of your feed mill. The inspection found 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).
The inspection found your firm failed to label 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.
Your procedures for cleaning out and/or flushing equipment after mixing feeds containing prohibited material are not adequate to prevent the cross-contamination of feeds not formulated to contain prohibited material.
You should establish adequate procedures and verify that the flush/clean-out method you use cleans out the remainder of preceding batches containing prohibited materials. Note: If you flush with feed ingredients, or sequence with non-ruminant feed, you must also label these products with the required cautionary statement "Do not feed to Cattle or Other Ruminants".
The deviations from regulations as noted above cause products being manufactured and distributed by your facility to be adulterated within the meaning of Section 402(a)(4) and misbranded within the meaning of Section 403(f) 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, such as seizure and/or injunction, without further notice.
You should notify this office in writing within 15 working days of 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 violations, and prevent their recurrence. If corrective action cannot be completed in 15 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 reply should be directed to Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237, telephone (513) 679-2700 extension 167.