Bacalao Giraldo, S.L.U. – FDA Warning Letter, May 21, 2024

The FDA conducted an inspection of Bacalao Giraldo S.L.A.'s seafood processing facility in Spain on May 20-21, 2024, identifying serious violations of the seafood HACCP regulation (21 CFR 123). The firm's refrigerated and frozen desalted cod in modified atmosphere packaging products are deemed adulterated. The FDA issued an FDA-483 and found the firm's subsequent responses inadequate. Key violations include a HACCP plan lacking adequate critical limits for controlling Clostridium botulinum growth and toxin formation in reduced oxygen packaging (ROP) (21 CFR 123.6(c)(3)), specifically regarding oxygen levels and temperature control during distribution. Additionally, the firm failed to list the refrigerated finished product step as a critical control point for C. botulinum (21 CFR 123.6(a) and (c)(2)) and did not identify undeclared allergens as a reasonably likely food safety hazard in its HACCP plan (21 CFR 123.6(a) and (c)(1)). The FDA requires a written response within fifteen working days, outlining specific corrections, including updated HACCP plans and five consecutive days of monitoring records. Failure to comply may result in refusal of admission for imported products under section 801(a) of the Act, including detention without physical examination (DWPE) via Import Alerts 16-120 and 16-125.