California’s Yamaya USA Inc., a seafood processor and importer based in Torrance, responded quickly in April to inspection findings from the U.S. Food and Drug Administration (FDA).
Yamaya facilities were inspected last April 7-13, and processor/importer responded to the FDA in writing on April 21. It promised to:
- Change critical limits in its Hazard Analysis and Critical Control Points (HACCP) to prevent pathogen growth.
- Maintain product temperatures during thawing, coloring and draining of salted and salted seasoned products and set temperatures for proper storage to make sure
- Add hazard of undeclared allergens to HACCP plan for frozen Capelin Roe.
- Ordered two recording thermometers for process room.
FDA, however, was not satisfied with Yamaya’s response. In a July 19 warning letter to Yamaya, the agency said the company did not provide sufficient documentation. FDA wants a copy of Yamaya’s revised HACCP plan along with documentation for all corrections made.
In the warning letter, FDA said Yamaya did not have an adequate HACCP plan at the time of the inspection.
It said as an importer, the company must adhere to U.S. requirements that imports are “processed under conditions equivalent to those required of domestic processors…”
Yamaya did not perform “affirmative steps” to ensure equivalency was met.
FDA also found Yamaya’s Capelin Roe and Pollack Roe products are adulterated. Corrective actions contained in both the HACCP plan for Pollack Roe and for Capelin Roe for thawing, coloring, seasoning, draining and labeling were not sufficient.
“We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. ¬ß381(a)), including placing them on “detention without physical examination,” and/or seize your product(s) and/or enjoin your firm from further violating the Act, the letter warns.
The Torrance processor/importer was given 15 working days to respond to the FDA warning letter.
FDA sent a July 18 warning letter to Ohio’s Pacific Food Inc., which owns a seafood processing facility in Columbus.
After a Feb. 18-25 inspection, FDA said Pacific’s sushi is adulterated and its shrimp roll adulterated and misbranded because of inadequacies in the company’s seafood HACCP.
The plan does not address pathogen growth and toxin formation that may occur during storage of it sushi rolls. The food safety hazards of histamine formation, pathogen growth and potential toxin formation are not addressed during thawing and storage of frozen vacuum-packed tuna.
The shrimp roll is misbranded for declaring the correct species.
Pacific Food was also given 15 working days to respond to FDA’s warning letter.
