Nicalapia S.A. – FDA Warning Letter, Aug 16, 2011

The FDA issued a Warning Letter to Nicalapia S.A. following an August 15-16, 2011 inspection and subsequent review of the firm's April 9, 2012 response. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, rendering the firm's scombrotoxin (histamine) forming fish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies include the failure to have HACCP plans that list adequate critical limits for histamine control at the Receipt of Raw Material critical control point, as required by 21 CFR 123.6(c)(3). Additionally, the firm's HACCP plans lacked adequate monitoring procedures and frequencies for each critical control point (21 CFR 123.6(c)(4)) and contained inappropriate corrective actions (21 CFR 123.7(b)). Furthermore, the firm failed to conduct a proper hazard analysis to identify all reasonably likely food safety hazards, specifically undeclared allergens like finfish, as required by 21 CFR 123.6(a) and (c)(1). Nicalapia S.A. must respond within thirty working days, outlining specific corrections, providing revised HACCP plans, and at least five product days of monitoring records. Failure to adequately respond may result in refusal of admission for imported products, including detention without physical examination (DWPE) under Import Alert #16-120.