FDA WARNING_LETTER - Sun Boricua, Inc. - June 06, 2012

The FDA inspected Sun Boricua, Inc.'s seafood manufacturing establishment in Camuy, Puerto Rico, from June 1-6, 2012, revealing serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). As a result, the firm's seafood products, including Delicias del Mar brand shrimp, lobster, marlin, and crab seafood tacos, are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to unsanitary conditions. Key deficiencies included the failure to conduct a hazard analysis and implement a written HACCP plan for seafood tacos to control hazards like pathogen growth, biological toxin, and scombrotoxin formation, as required by 21 CFR § 123.6(a) and (b). The firm also lacked a HACCP plan listing critical control points and critical limits (21 CFR § 123.6(c)(2) and (c)(3)). A submitted HACCP plan was deemed inadequate because it was not product-specific, failed to identify "thawing" as a Critical Control Point for marlin (scombrotoxin), and did not identify all product hazards (e.g., allergens, metal inclusion). Additionally, the plan was undated and unsigned (21 CFR § 123.6(d)(1)), and no evidence was provided to demonstrate compliance with HACCP training requirements (21 CFR § 123.10). The FDA requires a written response within fifteen working days, detailing specific corrections, including a compliant HACCP plan, CCP monitoring records (21 CFR § 123.6(c)(4)), a corrective action plan (21 CFR § 123.7(b)), and sanitation monitoring records (21 CFR § 123.11(b) and 21 CFR Part 110). Failure to correct these violations could lead to product seizure, injunction, and re-inspection fees.