Inspections, Compliance, Enforcement, and Criminal Investigations
Parrish & Heimbecker Limited 18-Nov-04
Department of Health and Human Services
Public Health Service
November 18, 2004
In reply refer to Warning Letter SEA 05-07
William B. Parrish, Chairman of the Board
Parrish & Heimbecker Limited
360 Main Street
Winnipeg, Manitoba, R3C 323 Canada
Dear Mr. Parrish:
An inspection of your feed mill operation, Conway Feed, Inc., located at 18700 Main Street, Conway, Washington, conducted by a Washington State Department of Agriculture Investigator, on June 17, 18 and 22, 2004, under contract with the Food and Drug Administration (FDA), found significant deviations from the requirements set forth in Title 21, Code of Fedederal Regulations, Part 589.2000 (21 CFR 589.2000) Animal Proteins Prohibited in Ruminant Feed. The regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause products being manufactured and/or distributed by this facility to be adulterated within the meaning of Section 402(a)(4) and misbranded within the meaning of Section 403(a) and 403(f) of the Federal Food, Drug and Cosmetic Act (the Act).
Our investigation found that because you failed to adequately inspect the label of a raw material, au ingredient with the cautionary statement “Do Not Feed to Cattle or Other Ruminants” was used in the manufacture of your finished product, Game Bird Crum/Pellet. Your final product, however, did not have the cautionary statement. Because this fish meal may have contained prohibited animal proteins, any product produced with it must have the cautionary label. See 21 CFR 589.2000(d)(1).
The investigation also revealed that the label of your Game Bird Crum/Pellet feed did not list fish meal as an ingredient. According to the information we collected during the inspection fish meal is routinely added to this ration. All ingredients are required to be listed on the label in descending order of predominance by weight. See 21 CFR 501.4(a).
The above is not intended to be an all-inclusive list of deviations from the regulations. 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 such violations do not recur. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
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 Iaw. 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 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.
Please send your reply to the Food and Drug Administration, Attention: Bruce Williamson, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Mr. Bruce Williamson at (425) 483-4976.
If you have questions regarding any issue in this letter, please contact Mr. Bruce Williamson at (425) 483-4976.
Charles M. Breen
cc: Scott C. McKnight, General Manager
Conway Feed Inc.
18700 Main Street
Conway, WA 98238-0576
Enclosure: Form FDA 483
Small Entity Compliance Guide