| Public Health Service Food and Drug Administration |
Southwest Region |
Department of Health and Human Services
October 28, 2011
Ref: DEN-12-02 WL
WARNING LETTER
VIA UPS Overnight Mail
Ms. Peggy I. Whiting, President
Hayai Zushi
307 West 600 South
Salt Lake City, Utah 84101
Dear Ms. Whiting:
We inspected your seafood processing facility, located at 307 West 600 South, Salt Lake City, Utah, on July 11-13, 15, 2011. We found that you have violations of the seafood Hazard Analysis and Critical Control Points (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 to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 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). Accordingly, your ready-to-eat seafood spring rolls and ready-to-eat squid salads 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 process 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 reasonable likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for ready-to-eat seafood spring rolls to control the food safety hazard of pathogen growth and toxin formation from the growth of Clostridium botulinum as well as major food allergens at the labeling step.
2. 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 safety of water, prevention of cross-contamination from insanitary objects, 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 RTE seafood spring rolls and/or sanitation corrections for any of the above areas of sanitation. Specifically, you do not have any sanitation monitoring records for your ready-to-eat seafood products that include spring rolls and squid salads.
3. 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 three of the eight steps of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 110. For example:
Prevention of cross-contamination from insanitary objects:
• A wooden handled knife was used during production of seafood spring rolls. One employee would wipe the blade of the knife after use with a sanitized towel but the knife handle was never wiped during the production of the seafood spring rolls.
• An employee put on gloves to prepare seafood spring rolls but then proceeded to collect materials from the walk-in cooler and the prep table cooler touching non-food contact surfaces such as that cooler handles, boxes, and containers. The employee then proceeded to prepare the ready-to-eat seafood spring rolls without changing the gloves.
Proper labeling and storage of chemicals:
• A bottle of bleach was being stored above recently cleaned processing equipment.
Protection of food, food packaging material, and food contact surfaces from adulteration:
• Cutting boards used during the production of seafood products are scored, creating a hard to clean surface.
• An employee would scrub the cutting boards with soap and waster and then wipe the soapy water off with a sanitized towel. The sanitizer instructions indicate that equipment should be washed, rinsed and then sanitized.
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 plans and sanitation monitoring 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: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (303) 236-3024.
Sincerely,
/S/
La Tonya M. Mitchell
Denver District Director
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