FDA WARNING_LETTER - Huwen Huang Import And Export Sa - August 25, 2013

The FDA inspected Huwen Huang Import and Export Sa. in Managua, Nicaragua, from August 23-25, 2013, and found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's (b)(4) products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to conduct a proper hazard analysis for (b)(4) products, specifically omitting pathogenic bacteria growth and toxin formation due to time/temperature abuse and inadequate drying as a reasonably likely food safety hazard (21 CFR 123.6(a) and (c)(1)). The FDA recommends establishing critical limits for a final water activity of 0.85 or below and ensuring a sufficiently short drying period. 2. Failure to list critical control points in the HACCP plan for (b)(4) products (21 CFR 123.6(c)(2)), specifically (b)(4) and (b)(4).

The firm's September 6, 2013, response was acknowledged but did not fully address the concerns. The company must respond in writing within 15 working days, outlining specific corrective actions, including a revised HACCP plan, five consecutive days of monitoring records, and any