Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations3
Issue DateSep 30, 2024
Product TypeFood & Beverages
StatusOpen
Letter Details
Firm
Bacalao Giraldo, S.L.U.
Location
Mr. Roberto Urrutia Beaskoa
CEO, Managing Director
Bacalao Giraldo, S.L.U.
Pol. Ind. Goiain
San Blas No. 7 Int, Goiain
01170 Legutiano Álava
Spain
Roberto.Urrutia@giraldofoodgroup.com
FEI Number
N/A
Country
Spain
Issue Date
September 30, 2024
Issuing Office
Center for Food Safety and Applied Nutrition
Product Type
Food & Beverages
Status
Open
Summary
Bacalao Giraldo, S.L.U., a seafood processing facility in Spain, failed to establish and implement a compliant Hazard Analysis and Critical Control Points (HACCP) plan for its refrigerated and frozen desalted cod products in modified atmosphere packaging, rendering them adulterated under federal law. During a May 2024 inspection, the FDA identified serious violations of 21 CFR 123, including the facility's failure to establish critical limits as required by the seafood HACCP regulation. The company's subsequent responses to FDA observations in June, July, and August 2024 were deemed inadequate to address the fundamental HACCP compliance deficiencies.
Bacalao Giraldo, S.L.U. FDA Warning Letter, September 30, 2024