DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510-337-6700
VIA FEDERAL EXPRESS
Our Reference: 2945025
April 23, 2002
WARNING LETTER
Anthony S. Friscia, President
A. Friscia Seafoods, Inc.
555 Francisco Street
San Francisco, California 94133
Dear Mr. Friscia:
On November 19-20 and December 3, 2001, we inspected your seafood processingfacility, located at 555 Francisco Street, San Francisco, CA. We found thatyou have serious deviations from the seafood HACCP regulations in Title 21,Code of Federal Regulations, Part 123 (21 CFR 123). These deviations cause yourAhi, Mahi, Tombo Tuna, and Cooked Crab to be adulterated within the meaningof Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act),in that the fishery products have been prepared, packed, and held under insanitaryconditions whereby they may be rendered injurious to health. You may find theAct and the seafood HACCP regulations through links in FDA? s home page at www.fda.gov.See attached handout, which gives information on how to obtain the Fish &Fisheries Products Hazards & Controls Guidance, 3ti edition, June 2001.
Your serious HACCP deviations are as follows:
1. You must have a HACCP plan that lists the critical limits that must be metto comply with 21 CFR 123.6(c)(3). However, your firm? s HACCP plans for Ahi,Mahi, and Tombo Tuna list critical limits, "Cooler temp not to exceed [redacted]degrees F for more than 4 hours in a 24 hour period. Cooler temp not to exceed[redacted] degrees F control cumulative," at the receiving critical controlpoint that is not adequate to control histamine formation.
FDA recommends that either:
All lots received are accompanied by transportation records (e.g., temperaturerecording chart) that show the fish were held at or below 40?F throughout transit
OR
For fish held under ice or other cooling media at the time of delivery--thereis an adequate quantity of ice or other cooling media to completely surroundthe product
OR
For fish delivered with a total transit time of 4 hours or less, the internaltemperature of a representative number of fish in the lot at the time of deliveryis not more than 40?F.
2. You must have a HACCP plan that lists the critical control points to complywith 21 CFR 123.6(c)(2). However,
- Your firm?s HACCP plans for Ahi, Mahi, and Tombo Tuna do not list the critical control point of storage for controlling the food safety hazard of scombrotoxin formation. FDA recommends that refrigerated seafood products be held at 40?F or less and that the temperature be monitored continuously by means of a temperature data recorder or by using an alarm system.
- Your firm?s HACCP plan for Cooked Crab does not list the critical control point of storage for controlling the food safety hazard of bacterial pathogen growth. FDA recommends that refrigerated seafood products be held at 40?F or less and that the temperature be monitored continuously by means of a temperature data recorder or by using an alarm system.
3. Since you chose to include corrective actions in your HACCP plan, your describedcorrective actions must be appropriate to comply with 21 CFR 123.7(b). However,your corrective action plan for Cooked Crab at the cooking critical controlpoint is not appropriate. Your corrective action plan does not address the correctiveaction to be taken when your time-temperature critical limit is not met (i.e.,[redacted]minutes at [redacted] degrees F). Your corrective action plan should also addresscorrecting the cause of the deviation and ensuring that unsafe product (i.e.,under-processed product) does not reach consumers.
4. You must maintain sanitation control records that document the monitoringand corrections applied to the following to comply with 21 CFR 123.1l(c):
- Safety of water
- Condition and cleanliness of food-contact surfaces
- Prevention of cross-contamination
- Maintenance of hand-washing, hand-sanitizing, and toilet facilities
- Protection from adulterants
- Labeling, storage, and use of toxic compounds
- Employee health conditions
- Exclusion of pests
5. You must have a HACCP plan that lists the food safety hazards that are reasonablylikely to occur, to comply with 2 1 CFR 123.6(c)( 1). However, your firm?s HACCPplan for Cooked Crab does not list the food safety hazard of natural toxins.
6. You must adequately monitor sanitation conditions and practices during processing,to comply with 21 CFR 123.1 l(b). However, your firm did not monitor the followingareas of sanitation with sufficient frequency to ensure control:
a. Your firm failed to monitor the condition and cleanliness of food contactsurfaces as evidenced by our investigator observing an employee using a telephonewhile wearing latex gloves and subsequently handling ready-to-eat crabmeat withoutwashing and sanitizing the gloves.
b. Your firm failed to prevent cross-contamination from insanitary object tofood or food-packaging material as evidenced by our investigator observing employeesroutinely packing ready-to-eat crabs into recycled boxes that were previouslyused to package fresh and frozen crabs.
At the conclusion of the inspection, the deviations were listed on Form FDA483 and discussed with you. A copy of this form is enclosed for your ready reference.This list is not meant to be an all-inclusive list of violations. You are responsiblefor ensuring that your processing facility operates in compliance with the Act,the seafood HACCP regulations, and the Good Manufacturing Practice regulations(21 CFR 110).
We may take further action if you do not promptly correct these violations.For instance, we may take further action to seize your products and/or enjoinyour firm from operating.
Please respond in writing within fifteen (15) working days of receipt of thisletter. More than four months have elapsed since FDA inspection. Please providethis office with information on what progress you have made in achieving FDAcompliance with the seafood HACCP regulations. You may wish to include in yourresponse documentation that would assist us in evaluating your corrections.If you cannot complete all corrections before you respond, we expect that youwill explain the reason for your delay, and state when you will correct anyremaining deviations.
Your response should be directed to: Ms. Harumi Kishida, Compliance Officer,U.S. Food and Drug Administration, 143 1 Harbor Bay Parkway, Alameda, CA 94502-7070.
If you have any questions regarding any issue in this letter, please contactMs. Kishida at (510) 337-6824.
Sincerely,
Dennis K. Linsley
District Director
San Francisco District
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