Pacific Exchange Distributors, Llc 12/28/10

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

December 28, 2010  

WL 18-11

Tokuhiro J. Nashiro, Plant Manager
Pacific Exchange Distributors, LLC.
405 East 149th St, Gardena, CA, 90248

Dear Mr. Nashiro:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at 405 East 149th St, Gardena, CA, 90248 on September 23-28, 2010.  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 California and Futomaki sushi rolls containing imitation crab meat and your Onigiri rice balls containing tuna, salmon, and mackerel 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.

Your significant violations were as follows:

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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b).  However your firm does not have HACCP plans for your sushi rolls containing imitation crab meat; and for your rice balls containing tuna, salmon, and mackerel, to control the food safety hazard of pathogen growth and potential toxin formation, for example Listeria monocytogenes growth and Bacillus cereus growth and toxin formation.

In addition, HACCP plans for products that contain allergenic substances need to include the allergenic reactions as a potential food safety hazard to be controlled as part of the HACCP program, and the plans for these products need to include a control strategy to identify those allergenic substances on the containers, to alert consumers.  

2. You must monitor sanitation conditions and practices during processing 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 prevention of cross-contamination from insanitary objects to food with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced by:

a) An employee was observed touching his gloved hand to his nose and then proceeding to roll ready-to-eat California Rolls without changing out his glove. 

b) An employee was observed handling a waste receptacle with his gloved hand and then proceeding to roll ready-to-eat California Rolls without changing out his glove.

3. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11( c).  However, your firm did not maintain sanitation monitoring records for the safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice; condition and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects to food; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; and control of employee health conditions required for the processing of sushi rolls and rice balls that are made on a daily basis.

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 from your 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 Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: 

Blake Bevill
Director Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA, 92612-2506

If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at 858-550-3850 x106.

Sincerely,

/s/

Alonza E. Cruse
District Director
Los Angeles District