FDA WARNING_LETTER - Tang Sang Hah Co., Ltd.

The FDA issued a Warning Letter to Tang Sang Hah Co., Ltd. following an inspection that revealed deviations from Seafood HACCP requirements for their fermented fish sauce. The FDA obtained a copy of the firm's HACCP documentation, and its evaluation found the fish sauce products to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under conditions that may render them injurious to health.

Significant deviations include: 1. **Lack of Critical Control Points (CCPs):** The HACCP plan for fermented fish sauce does not list CCPs to control identified hazards of *Clostridium botulinum* toxin formation and histamine. The FDA recommends identifying the receiving step as a CCP for histamine formation, ensuring fish are fully iced or transported below 4.4°C, and monitoring internal temperatures and conducting sensory examinations upon off-loading. The firm needs to assess the need for CCPs addressing cumulative exposure times to control *Clostridium botulinum* growth and toxin formation and histamine until full fermentation (shelf stability) is achieved, limiting exposure to temperatures above 21°C to 2 hours until Aw <0.85 or WPS >20%. Additionally, the firm must address pre-formed *Clostridium botulinum* toxin, recommending a 10-minute boiling step for uneviscerated fish or finished product, or providing scientific study demonstrating