source:http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm298410.htm
Enforcement Actions
Warning Letters
Enforcement Actions
Warning Letters
2012
-
American Fish & Seafood Co. 3/29/12
Department of Health and Human Services logoDepartment of Health and Human Services
Public Health Service
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone:(510) 337-6700
VIA UNITED PARCEL SERVICE
Our Reference: FEI 3001236787
March 29, 2012
Jack King, President
Prospect Enterprises, Inc.
625 Kohler Street
Los Angeles, California 90021
WARNING LETTER
Dear Mr. King:
We inspected your seafood processing facility, American Fish & Seafood Company, located at 7600 Wilbur Way, Sacramento, California, on January 23, 25, 30, 2012 and February 2, 2012. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of Part 123, renders the fish or 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 chilled, histamine-forming fish such as tuna, chilled, vacuum packaged Hamachi and tuna, refrigerated ready-to-eat products such as vacuum packaged smoked salmon and trout, pasteurized canned crabmeat, are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA’s home page at www.fda.gov.
At the close of our inspection, the investigators provided Matthew Berenstein, Interim General Manager, with the form FDA 483, which presents their evaluation of your firm’s performance regarding various aspects of the HACCP requirements. We attached a copy of the FDA 483 for your reference. During the FDA close-out meeting, (b)(4), provided the investigators your firm’s HACCP plans for “Refrigerated Vacuumed Packed Smoked Fish and Ready to Eat Seafood Products” and “Refrigerated Vacuumed Packed Scombroid Fish Products” dated 2-2-12, and your firm’s “Fresh Product Receiving Checklist.”
The deviations listed in this letter are based on the inspection and our evaluation of your firm’s HACCP plans, signed and dated 6-25-11 and 2-2-12, which revealed the following significant violations:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for “Raw, fresh, histamine producing finfish Tuna, mackerel, mahi-mahi, yellowtail, sardine, bonito,*escolar. Whole, dressed, loins, fillets, or steaks [*Gemmpylotoxin]” does not list the food safety hazard of pathogen growth and toxin formation for the Sashimi grade fish intended for raw consumption at the Receiving (fresh only) and Cooler Strorage (fresh only) critical control points (CCPs).
2. You must have a HACCP plan that at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However,
(a) Your firm’s HACCP plan for “Raw, fresh, histamine producing finfish Tuna, mackerel, mahi-mahi, yellowtail, sardine, bonito,*escolar. Whole, dressed, loins, fillets, or steaks [*Gemmpylotoxin]” lists a critical limit “(b)(4)” at the Cooler Storage (fresh only) CCP that is not adequate to control histamine formation as a result of time/temperature abuse. FDA recommends a maximum exposure time of eight (8) hours or less as long as the fish was not exposed to greater than 70°F during the entire exposure time. The cumulative exposure time should include transit, processing, and refrigerated storage. Please refer to Chapter 7 of the HACCP Guide, 4th Edition, for the appropriate monitoring procedures, corrective action, verification procedures, and record-keeping system that are applicable to your established critical limit.
(b) Your firm’s HACCP plan for “Refrigerated Vacuumed Packed Smoked Fish and Ready to Eat Seafood Products” which applies to “Refrigerated smoked and cured fish products and ready to eat products (ie. Imitation crab, seafood salads, etc)” lists a critical limit “(b)(4)” at the Receiving CCP that is not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin. FDA recommends: (1) for fish or fishery products, delivered refrigerated (not frozen), that all lots received are accompanied by transportation records that show that the product was held at or below 40°F; or (2) for products delivered under ice, that the product is completely surrounded by ice at the time of the delivery; or (3) for products delivered under chemical cooling media, such as gel packs, that there is an adequate quantity of cooling media that remain frozen to have maintained product at or below 40°F throughout transit AND the internal temperature of the product at the time of the delivery is below 40°F; or (4) for products delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less, the time of transit does not exceed 4 hours AND the temperature of the product does not exceed 40°F. Please refer to the Chapter 13 of the HACCP Guide, 4th Edition, for the appropriate monitoring procedures, corrective action, verification procedures, and record-keeping system that are applicable to critical limits established for your products.
(c) Your firm’s HACCP plan for “Refrigerated Vacuumed Packed Smoked Fish and Ready to Eat Seafood Products” which applies to “Refrigerated smoked and cured fish products and ready to eat products (ie. Imitation crab, seafood salads, etc)” lists critical limits “(b)(4)” at the Cooler Storage CCP, that is not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin. This critical limit is contradictory to the first critical limit for your Cooler Storage CCP. FDA does not recommend specifying a critical limit for cumulative exposure time of vacuum packaged products during refrigerated storage when temperatures exceed the temperature critical limit. These critical limits are not suitable to control the hazard because of the difficulty in tracking the specific products and the specific cumulative temperature exposures that each of those products experience.
(d) Your firm’s HACCP plan for “Refrigerated Vacuumed Packed Scombroid Fish Products” which applies to “Refrigerated vacuumed packed scombroid fish products (Hamachi, tuna, etc)” lists a critical limit “(b)(4)” at the Receiving CCP, that is not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin. For fish and fishery products with Time/Temperature Integrators (TTI), FDA recommends: (1) for products delivered refrigerated (not frozen), that all lots received are accompanied by transportation records that show that the product was held at or below 38°F throughout transit; or (2) for product delivered under ice, that the product is completely surrounded by ice at the time of delivery; or (3) for products delivered under chemical cooling media, such as gel packs, that there is an adequate quantity of cooling media that remain frozen to have maintained product at 38°F or below throughout transit AND the internal temperature of the product at the time of delivery is 38°F or below; or (4) for products delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less, that the time of transit does not exceed 4 hours AND the temperature of the product at the time of delivery does not exceed 38°F. To establish the appropriate monitoring procedures, corrective action, record-keeping, and verification procedures for your established critical limit, please refer to page pages 268 through 271, and page 278 of the HACCP Guide, 4th Edition.
(e) Your firm’s HACCP plan for “Refrigerated Vacuumed Packed Scombroid Fish Products” which applies to “Refrigerated vacuumed packed scombroid fish products (Hamachi, tuna, etc)” lists a critical limit “ (b)(4)” at the Cooler Storage CCP that is not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin. Please refer to our remarks on citation 2(c).
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However,
(a) Your firm’s HACCP plan for “Raw, fresh, histamine producing finfish Tuna, mackerel, mahi-mahi, yellowtail, sardine, bonito,*escolar. Whole, dressed, loins, fillets, or steaks [*Gemmpylotoxin]” lists a monitoring frequency “(b)(4)” at the Cooler Storage (fresh only) CCP, that is not adequate to control histamine formation. FDA recommends continuous monitoring by the device itself, with a visual check of the recorded data at least once per day.
(b) Your firm’s HACCP plans for “Refrigerated Vacuumed Packed Smoked Fish and Ready to Eat Seafood Products” which applies to “Refrigerated smoked and cured fish products and ready to eat products (ie. Imitation crab, seafood salads, etc)” and for “Refrigerated Vacuumed Packed Scombroid Fish Products” which applies to “Refrigerated vacuumed packed scombroid fish products (Hamachi, tuna, etc)” list a monitoring frequency “(b)(4)” at the Cooler Storage CCP, that is not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin. FDA recommends monitoring of the cooler temperature by a continuous temperature data recorder, with visual check of the monitoring instrument at least once per day. FDA no longer recommends high temperature alarms for monitoring temperatures in coolers.
4. You must implement monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b)( and (c)(4). However,
(a) Your firm has not been monitoring and recording the internal temperature of fish and fishery products at the Receiving CCP, to control pathogens and toxin formation, listed in your HACCP plan for “Fresh ready to eat products, fresh vacuum packaged ready to eat products smoked fish, pickled herring, seafood salads, and other cooked fish and shellfish. On December 27, 2011, your firm received Smoked Salmon and Smoked Trout from (b)(4), and the invoice # (b)(4) which serves as your HACCP monitoring record at the Receiving CCP, does not have records of internal temperatures of the products. On January 14, 2012, your firm received a shipment of Crab (b)(4) Meat and Anchovies Fillet from (b)(4), and the invoice (b)(4) does not have internal temperature readings listed.
(b) Your firm has not been monitoring and recording the internal temperature and the presence of adequate quantity of ice surrounding the fish and fishery products at the Receiving CCP, to control histamine formation, listed in your HACCP plan for “Raw, fresh, histamine producing finfish Tuna, mackerel, mahi-mahi, yellowtail, sardine, bonito,*escolar. Whole, dressed, loins, fillets, or steaks [*Gemmpylotoxin].” On January 23, 2012, your firm received a shipment of one case (b)(4) of fresh Tuna Loins from (b)(4). Although the invoice # (b)(4) had “iced” and “34°” recorded on the document, the FDA investigator observed that the case of fresh Tuna Loins was unopened with the white plastic shipping straps still intact.
5) Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for “Raw, fresh, histamine producing finfish Tuna, mackerel, mahi-mahi, yellowtail, sardine, bonito,*escolar. Whole, dressed, loins, fillets, or steaks [*Gemmpylotoxin]” at the Receiving CCP to control histamine formation, is not appropriate. Your corrective action does not provide for correction of the cause of the deviation when the critical limit is exceeded. FDA recommends discontinuing use of the supplier or carrier until evidence is obtained that transportation practices have changed.
6) You must monitor sanitation conditions and practices with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
(a) Condition and cleanliness of food contact surfaces – FDA observed that work tables in the fish cutting room and scales located in the Cooler No. 2 have fish residues on them.
(b) Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garment, and from raw product to cooked product – On January 23, 2012, FDA observed that prior to starting work and during your evening production, your employees handled various pieces of equipment, product cartons containing fish, utensils, and hoses without cleaning or sanitizing their hands. FDA also observed employees handling swordfish and Sashimi grade tuna loins without sanitizing their hands.
(c) Maintenance of hand washing, hand sanitizing, and toilet facilities – FDA observed that the hand wash sinks located in the receiving area, shellfish cooler, processing room, and employee restrooms did not have hot water.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should 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 violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), and the Current Good Manufacturing Practice regulation (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.
Please send your reply to the U. S. Food and Drug Administration, Attention: Darlene B. Almogela, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have questions regarding any issues in this letter, please contact Compliance Officer Erlinda Figueroa at (510) 337-6795.
Sincerely,
/S/
Barbara J. Cassens
District Director
San Francisco District
Fresh seafood
seafood processsor
