Inspections, Compliance, Enforcement, and Criminal Investigations
Bell's Fishery, Inc. 10-Dec-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
1560 East Jefferson Avenue
Detroit, MI 48207-3179
RETURN RECEIPT REQUESTED
December 10, 2001
Donald R. Beil, President
Bell?s Fishery, Inc.
229 S. Huron Street
Mackinaw City, MI 49701
Dear Mr. Bell:
On August 15th, 2001 the Food and Drug Administration (FDA) conducted an inspection of your facility located at 229 S. Huron Street, Mackinaw City, MI. The inspection was conducted to determine compliance with the FDA?s Seafood Hazard Analysis Critical Control Point (HACCP) Regulation (21 CFR 123) and the current Good Manufacturing Practice requirements for foods (GMP)(21 CFR 110).
During the inspection, the FDA investigators observed shortcomings in your system that are deviations from the principles of HACCP and the significant requirements of the program. The FDA investigators presented your firm with a form FDA-483 that provides the investigators? evaluation of your firm?s performance regarding various aspects of the HACCP and GMP requirements. In spite of some of the corrections you have made, we still find your firm is in violation of21 CFR 123 and 110 causing your products to be deemed adulterated under the provisions of 21 U.S.C. 342(a)(4) because of the following:
1. You must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, in order to comply with 21 CFR 123.6(b). However, your firm does not have a HACCP plan for whitefish sausage to control the food safety hazard of pathogen growth.
2. You must implement the monitoring procedure of recording storage cooler temperatures 3 times per day listed in your "Smoked Fish" HACCP plan, in order to comply with 21 CFR 123.6(b). However, your firm failed to perform and document as outlined in your "Smoked Fish" HACCP plan the storage cooler temperatures of 9 of 12 records (lot numbers 62101,62901, 7801, 71801, 72501, 73001, 8201, 8501, & 8801).
3. You must have sanitation control records that document monitoring and corrections, in order to comply with 21 CFR 123.11(c), However, your firm lacked sanitation monitoring records for "Smoked Whitefish" for 12 of 12 lots reviewed (lot numbers 62101, 62901,7401,7801, 71801, 72501, 73001, 8201, 8501, 8801, 81101, & 81301).
The above-identified deviations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the federal regulations.
You should take prompt measures to correct these deviations, Failure to promptly correct the deviations noted may result in regulatory action without further notice. Such action includes seizure or injunction.
Please notify this office in writing, within fifteen(15) working days of receipt of this letter, of the specific steps you have taken to correct these violations, including an explanation of each step taken to prevent their reoccurrence. If corrections cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Also, please include copies of any available documentation demonstrating that corrections have been made.
Your written reply should be directed to David M. Kaszubski, Director Compliance Branch, U.S. Food and Drug Administration, 1560 E. Jefferson, Detroit, MI 48207, telephone (313) 226-6260 ext, 185.Sincerely,
Joann M. Givens