Independent Seafoods Panama, S.A. dba Panama Artisanal Seafoods FQ

Warning LetterOpen

Mr. Miguel Molina Owner Independent Seafoods Panama, S.A. dba Panama Artisanal Seafoods FQ Juan Diaz, Avenida 1b Sur Calle San Francisco, San Felipe Panama City Panama PanamaFEI 3018985231Issued Nov 3, 2023Center for Food Safety and Applied Nutrition

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3018985231.

Violations2

Issue DateNov 3, 2023

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: Independent Seafoods Panama, S.A. dba Panama Artisanal Seafoods FQ
Location: Mr. Miguel Molina Owner Independent Seafoods Panama, S.A. dba Panama Artisanal Seafoods FQ Juan Diaz, Avenida 1b Sur Calle San Francisco, San Felipe Panama City Panama Panama
FEI Number: 3018985231
Country: N/A
Issue Date: November 03, 2023
Issuing Office: Center for Food Safety and Applied Nutrition
Product Type: Food & Beverages
Status: Open

Summary

Independent Seafoods Panama, S.A. failed to comply with seafood Hazard Analysis and Critical Control Point (HACCP) regulations under 21 CFR Part 123 during an FDA inspection conducted June 12-13, 2023, rendering their fresh artisanal fish and histamine fish products adulterated. The company did not conduct proper hazard analysis for each type of fish and fishery product produced to identify food safety hazards reasonably likely to occur, nor did they implement compliant HACCP plans as required. These serious violations meant the seafood products were prepared, packed, or held under conditions whereby they may have been rendered injurious to health.

Independent Seafoods Panama, S.A. dba Panama Artisanal Seafoods FQ FDA Warning Letter, November 3, 2023