FDA WARNING_LETTER - 100Misterios, LDA - April 05, 2024

The FDA inspected 100Misterios, LDA, a Portuguese low-acid and seafood manufacturer, from April 3-5, 2024, identifying serious deviations from seafood HACCP (21 CFR 123), Emergency Permit Control (21 CFR 108), and LACF (21 CFR 113) regulations. An FDA-483 was issued, and the firm's subsequent response was deemed inadequate. Key seafood HACCP violations included failure to conduct proper hazard analyses, not listing critical hazards like Staphylococcus aureus and undeclared allergens, and inadequate critical control points, limits, monitoring procedures, and corrective actions for various seafood products. For LACF products, the firm failed to adhere to its scheduled process for canned sardines in olive oil, specifically regarding retort basket loading and the unfiled addition of lemon slices, without notifying FDA of these changes. Additionally, HACCP plans improperly grouped fish with differing hazards and omitted several products entirely. These violations render the firm's products adulterated under the FD&C Act. 100Misterios, LDA must respond within 15 working days with specific corrective actions and supporting documentation. Failure to comply may result in refusal of admission for imported products, including Detention Without Physical Examination (DWPE) under Import Alerts #99-38 and #16-120. The firm is responsible for ensuring compliance with all applicable regulations.