Inspections, Compliance, Enforcement, and Criminal Investigations
Seafood Supplies 24-Oct-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
VIA FEDERAL EXPRESS
October 24, 2001
Our Reference: 2952455
William T. Dawson, Owner
San Francisco, California 94111
Dear Mr. Dawson:
We inspected your seafood processing facility, located at the above address, on September 24 and 25, 2001. We conducted this inspection to determine your compliance with FDA?s seafood processing regulations Title 21, Code of Federal Regulations, Part 123 (21 CFR 123) and the Good Manufacturing Practice requirements for foods (21 CFR 110).
We found that your firm has a serious HACCP deviation. This deviation causes your Yellowtail (Amberjack) to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) in that the fish have been prepared, packed or held under insanitary conditions whereby they maybe rendered injurious to health. We listed the deviation on a Form FDA 483 (Inspectional Observations) and discussed it with you at the conclusion of the inspection. Your serious HACCP deviation is as follows:
You must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(b). However, your firm does not have a written HACCP plan for Yellowtail (Amberjack) fish that you receive and repack at your facility, to control the food safety hazard of histamine formation as a result of time/temperature abuse, Please refer to the FDA?s Fish and Fishery Products Hazards & Controls Guide, Third Edition, for recommended controls that may be applicable to your operations.
You must immediately take appropriate steps to correct the deviation. We may initiate regulatory action without further notice if you do not correct it. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
Please respond in writing within fifteen working days from receipt of this letter. Your response should outline the specific things you are doing to correct the deviation. You may wish to include in your response documentation such as your HACCP plan and copies of completed monitoring records, or other useful information that would assist us in evaluating your correction. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deficiencies.
Please send your reply to the Food and Drug Administration, Attention: Erlinda N. Figueroa, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, California 94502-7070. If you have questions regarding any issue in this letter, please contact Ms. Figueroa at (510) 337-6795.Sincerely,
Dennis K. Linsley
San Francisco District