Empacadora Bilbo S.A.

7 records, newest first. Each line links to the FDA page it came from.

Refusal charges, in plain English

• MFRHACCP1 refused line

  Seafood HACCP requirements not met

  The seafood appeared to have been processed without meeting the seafood HACCP requirements in 21 CFR 123.6(a) and 123.8(a), so it is treated as prepared under insanitary conditions.

Questions about Empacadora Bilbo S.A.

Is Empacadora Bilbo S.A. on an FDA import alert?

Yes. As of October 26, 2026, Empacadora Bilbo S.A. is on the red list of FDA Import Alert 16-120, “Seafood from processors not in compliance with HACCP”, for frozen vacuum packaged fish; FDA published the listing on July 2, 2024.

Has FDA refused shipments from Empacadora Bilbo S.A.?

Yes. FDA refused 1 shipment line from Empacadora Bilbo S.A. on October 18, 2024. The most recent, on October 18, 2024, was tuna (albacore, yellowfin, bluefin, skipjack, etc.), charged as MFRHACCP (seafood haccp requirements not met).

Why did FDA refuse Empacadora Bilbo S.A.'s shipments?

The most frequent charge is MFRHACCP (seafood haccp requirements not met, 1 line).

Has Empacadora Bilbo S.A. received an FDA warning letter?

Yes. FDA issued a warning letter to Empacadora Bilbo S.A. on February 9, 2024 (Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions).

When was Empacadora Bilbo S.A. last inspected by FDA?

FDA's most recent inspection of Empacadora Bilbo S.A. with a final classification is dated July 28, 2023 and was classified OAI (Official Action Indicated).

What is Empacadora Bilbo S.A.'s FEI number?

Empacadora Bilbo S.A.'s FDA Establishment Identifier (FEI) is 3004290156.

Can shipments from Empacadora Bilbo S.A. still enter the U.S.?

Shipments of frozen vacuum packaged fish from Empacadora Bilbo S.A. can be detained without physical examination under Import Alert 16-120; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).