Inspections, Compliance, Enforcement, and Criminal Investigations
Prospect Enterprises, Inc. 20-Nov-03
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL EXPRESS
Our Reference: CFN 2939032
November 20, 2003
Ernest Y. Doizaki, Chief Executive Officer
Prospect Enterprises, Inc.
550 Ceres Avenue
Los Angeles, California 90013
Dear Mr. Doizaki:
On July 15 & 22, 23, and 29, 2003, we inspected your seafood processing
facility American Fish and/Seafood Company, located at 7754 Security Circle,
Reno, Nevada, and found that you have serious deviations from Title 21 of the
Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR
123.6(g), failure of a processor to have and implement a HACCP plan that complies
with this section, or otherwise operate in accordance with the requirements
of this part, renders the fishery products adulterated within the meaning of
Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21
U.S.C. 342(a)(4). Accordingly, your refrigerated histamine forming fish, e.g.,
tuna, mackerel, ,Mahi Mahi, Yellowtail, etc., and your refrigerated, ready-to-eat
fish and fishery products, e.g., smoked salmon, pickled herring, seafood salads,
fresh vacuum packaged ready-to-eat products, and other cooked fish and shellfish
are adulterated, in that the products have, been prepared, packed, or held under
insanitary condition to health. You may find whereby they may have been rendered
injurious to Health. You may find the Act and the Seafood HACCP regulation through,
links in FDAs homepage at www.fda.gov.
See attached handout on how you can obtain a copy of the Fish & Fisheries
Products Hazards & Controls Guidance, 3rd edition, June 2001. We listed
the deviations on a Form FDA-483 and discussed them with James W. Ball, General
Manager, at the conclusion of the inspection. We are enclosing a copy of the
FDA-483 for your reference. Your serious HACCP deviations were as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR Part 123.3(f) as any biological, chemical, or physical property that may cause a food to be unsafe for human consumption". However, your firms HACCP plan for Fresh ready to eat products, fresh vacuum packaged ready to eat products smoked fish, pickled herring, seafood salads, other cooked fish and shellfish, does not list the food safety hazard of histamine formation in Pickled Herring 4 a result of time/temperature abuse.
2. You must have a HACCP plan that, at a minimum, lists adequate monitoring procedures for each critical control point, to comply with 21 CFR 123.6(c)(4).
(a) Your firms HACCP plan Fresh ready to eat products, fresh vacuum packaged
ready to eat products, smoked fish, pickled herring, seafood salads, other cooked
fish and shellfish lists monitoring procedures at the receiving critical
control point that not adequate to control pathogens. FDA recommends that for
ready-to-eat fish and fishery products delivered refrigerated (hot frozen),
the firm monitor the internal temperature of the fishery product throughout
transit; or monitor the temperature of the truck or other carrier
throughout transportation; or for fishery products with transit times of four hours or less, taking the internal temperature of a representative number of fishery product in the lot at the time of delivery; or monitor the adequacy of ice or chemical cooling media at the time of delivery. Your HACCP plan lists that you will monitor temperature at receiving by taking the internal temperature of three fish from each lot using a dial or digital thermometer. However, since this monitoring procedure is recommended only when transit times are less than four hours and discussions during the inspection revealed that products are received from [redacted] an [redacted] where transit times would exceed four hours, your monitoring procedures are considered inadequate.
If, however, you do receive product where you are confident the transit time was less than four hours, and you intend to implement taking the internal temperature of a representative number of fish, you will need to carry out monitoring in an accurate manner using the appropriate equipment. During our inspection, your firm was observed using a [redacted] surface temperature thermometer (especially on July 15, 2003) to determine surface temperatures, rather than using a dial or digital thermometer* and taking actual internal temperatures of the fish at receiving.
(b) In addition, your firms HACCP plan for Raw, fresh, histamine producing finfish tuna, mackerel, mahi mahi, yellowtail, sardine, bonito, Whole, dressed, loins, fillet, steaks lists monitoring procedures at the receiving critical control point that are not adequate to control histamine. Your plan states that the product must be iced or show evidence that temperatures did not exceed 40°F by monitoring internal temperatures and shipping temperature with a dial or digital thermometer at receiving.
For secondary processors receiving histamine forming species, FDA recommends that refrigerated fish be received accompanied by transportation records that show the fish were held at or below 40°F throughout transit or for fish held under ice or chemical cooling media that the product be surrounded by an adequate amount of ice or cooling media at the time of delivery. Taking internal temperatures of a representative number of fish in the lot is acceptable when transit times are less than four hours. Your monitoring procedures do not adequately fulfill any of these recommendations.
If you intend to monitor the temperature of the carrier throughout transportation, your HACCP plan must indicate the use of time/temperature data loggers or recorder thermometers that continuously monitor the ambient air temperature during transit. Internal temperature of the fish may be monitored in lieu of ambient air temperature.
If you intend to monitor for the presence of ice, your HACCP plan must list monitoring procedures that include a visual observation for the adequacy of ice surrounding the product.
If transit times are known to be less than four hours and you intend to take internal temperatures of a representative number of fish, you will need to use appropriate monitoring procedures and equipment. Again, as discussed above, the use of [redacted] surface temperature thermometer to the surface temperature is not adequate when internal temperature is to be monitored.
You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11 (b). However, your firm did not monitor key sanitation areas with sufficient frequency to ensure control of:
(a) Safety of water - FDA observed that a water supply to the sink in the raw fish cutting area and hot and cold water lines have dead legs and/no backflow prevention devices to these lines.
(b) Condition and cleanliness of food contact surfaces, including utensils,
gloves, and outer garments - On July 15 and 22, 2003, FDA observed that plastic
carts used to transport fish and live shellfish had thick layers of dried fish
protein and debris.
(c) Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments and from raw product to cooked product - On July 15, 2003, FDA observed a corrugated box of uncovered cooked crab placed within one foot of a barrel filled with garbage and within two feet of a work cart with raw fish. FDA also observed that employees were handling seafood, processing equipment, and packaging material without washing hands or changing gloves between operations.
(d) Maintenance of hand washing, hand sanitizing, and toilet facilities - Lack of a hand washing sink in the fish cutting area; the double basin sink in the fish cutting area had separate hot and cold water faucets, and no means for washing hands in warm running water.
(e) Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants - On July 15, 2003, FDA observed in the raw fish fillet area that a wet rag was placed oh top of plastic packaging material. Both the wet rag and the plastic packaging were sitting in a dirty blue plastic crate. FDA also observed a hose lying on the floor in the raw fish fillet area and when wrapped up in the hose carrier, dripped water into a box of uncovered fish sitting on the counter.
(f) Exclusion of pests from the food plant - FDA observed the presence of flies
in the processing area.
4. You must maintain sanitation control records that, at a minimum, document the monitoring and corrections, to comply with 21 CFR 123.11(c). However on July 23, 2003, the Sales/HACCP Manager conducted a post-production walk through sanitation audit and did not document the presence of several flies in the fish cutting area.
You must immediately take appropriate steps to correct the violations. 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 enjoin your firm from operating.
Please respond in writing within fifteen (15) working days of receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You may wish to include in your response documentation such as copies of the revised HACCP plan, HACCP monitoring records, or other useful information that would assist us in evaluating your corrections. 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 deviations.
This letter may not list all the deviations at your facility. You are responsible
for ensuring that your processing plant operates in compliance with the Act,
the Seafood HACCP regulations and the current Good Manufacturing Practices (21
CFR Part 110). You also have a responsibility to use procedures to prevent further
violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Your response should be directed to: Ms. Erlinda N. Figueroa, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have any questions regarding any issue in this letter, please contact Ms. Figueroa at (510) 337-6795.
Charles D. Moss, Acting Director for Dennis K. Linsley
San Francisco District