Seiki, Inc.

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

Refusal charges, in plain English

• MFRHACCP6 refused lines

  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.

• VETDRUGRES5 refused lines

  Animal drug residue

  The product appeared to contain a new animal drug, or a conversion product of one, that is unsafe within the meaning of section 512 of the FD&C Act.

Questions about Seiki, Inc.

Is Seiki, Inc. on an FDA import alert?

Yes. As of October 25, 2026, Seiki, Inc. is on the red list of FDA Import Alert 16-124, “Aquaculture seafood: unapproved drugs”, for amberjack yellowtail buri; hamachi yellowtail collar buri; FDA published the listing on August 15, 2024.

Has FDA refused shipments from Seiki, Inc.?

Yes. FDA refused 11 shipment lines from Seiki, Inc. between November 16, 2017 and February 10, 2025. The most recent, on February 10, 2025, was aquaculture harvested fishery/seafood products, n.e.c.,, charged as VETDRUGRES (animal drug residue).

Why did FDA refuse Seiki, Inc.'s shipments?

The most frequent charges are MFRHACCP (seafood haccp requirements not met, 6 lines) and VETDRUGRES (animal drug residue, 5 lines).

When was Seiki, Inc. last inspected by FDA?

FDA's most recent inspection of Seiki, Inc. with a final classification is dated September 16, 2022 and was classified VAI (Voluntary Action Indicated).

What is Seiki, Inc.'s FEI number?

Seiki, Inc.'s FDA Establishment Identifier (FEI) is 3003688509.

Can shipments from Seiki, Inc. still enter the U.S.?

Shipments of amberjack yellowtail buri; hamachi yellowtail collar buri from Seiki, Inc. can be detained without physical examination under Import Alert 16-124; 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).