FDA WARNING_LETTER - ACPETAMAR De R.L. - April 19, 2013

On April 19, 2013, the FDA inspected Acpetamar De R.L.'s seafood processing facility in El Salvador, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The inspection resulted in an FDA-483, and the firm's May 28, 2013, response, including a revised HACCP plan, was deemed inadequate.

The FDA determined the firm's fish products are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)) because they were prepared, packed, or held under conditions that may render them injurious to health.

Key violations include: 1. **Inadequate HACCP Plan Critical Limits (21 CFR 123.6(c)(3)):** * The revised HACCP plan for "(b)(4)" lacked an adequate critical limit for sensory/organoleptic evaluation to control scombrotoxin (histamine) formation, specifically missing a critical limit value for decomposition. * No critical limit for internal temperature monitoring at the dock during off-loading from harvest vessels. The plan's "(b)(4)" temperature monitoring was unclear regarding location (dock vs. facility) and failed to address transportation conditions