FDA WARNING_LETTER - Hai Soon Leong Sdn Bhd - June 03, 2008

On November 7, 2008, the FDA issued a Warning Letter to Hai Soon Leong Sdn Bhd, following an inspection of their seafood processing facility in Malaysia on June 2 and 3, 2008. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110). These violations render the firm's salted seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Despite the firm's June 24, 2008, response to the FDA Form 483, which included a revised HACCP plan, continuing violations were identified. Specifically, the HACCP plan for salted fish failed to list critical control points for "Rinsing/Soaking Operation" and "Oven Drying" to control pathogen growth and toxin formation, violating 21 CFR 123.6(a) and (c)(2). The monitoring procedures and frequency for the "Defrosting" critical control point were inadequate, as checking temperature only at the "Start, middle and end of production" for a two-day defrosting period under refrigeration is insufficient to control pathogen growth, violating 21 CFR