Inspections, Compliance, Enforcement, and Criminal Investigations
King's Fish Market, Inc. 17-Dec-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
1560East Jefferson Avenue
Detroit, Ml 48207-3179
RETURN RECEIPT REQUESTED
December 17, 2001
Mr. Ernest R. King
King?s Fish Market, Inc.
Lake Street, Box 98
Naubinway, MI 49762
Dear Mr King:
On August 30th-31st, 2001 the Food and Drug Administration (FDA) conducted an inspection of your facility located at Lake St., Naubinway, 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 investigator observed shortcomings in your system that are serious deviations from the principles of HACCP and the significant requirements of the program. These deviations, some of which were previously brought to your attention, cause your whitefish roe and hot smoked fish products to be in violation of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. You can find this Act and the seafood HACCP regulations through links in FDA?s homepage www.fda.gov.
These deviations were as follows:
1. You must have a HACCP plan to control any food safety hazards that are reasonably likely to occur, in order to comply with21 CFR 123.6(b). However, your firm does not have a HACCP plan for whitefish roe to control the food safety hazard of Clostridium botulinum.
2. You are required to have sanitation control records that document monitoring and corrections, in order to comply with 21 CFR 123.11(c), However, your sanitation control records do not document the monitoring for the prevention of cross-contamination, protection of food and food packaging material and food contact surfaces from adulterants/contaminants, proper labeling and storage and use of toxic compounds, and exclusion of pests from the processing facilities.
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 Mr. David M. Kaszubski, Director Compliance Branch, U.S. Food and Drug Administration, 1560 E. Jefferson, Detroit, MI 48207, telephone (313) 226-6260 ext. 185.
Joann M. Givens