FDA Stories #026 — A Greek Seafood Processor's Marinated Anchovies Reached FDA's HACCP Detention List

Short answer: FDA placed ready-to-eat marinated anchovies and cold-smoked herring from Greek processor Filaretos Bros Co. on Import Alert 16-120 after an inspection found serious seafood HACCP deviations. The alert permits detention without physical examination of the listed products at the US border.

This article summarizes public FDA import-alert records. The company named in those records is not identified as an FDABridge client, and the alert entry does not report a recall or illnesses.

What happened to the Greek anchovies and smoked herring?

FDA's current Import Alert 16-120 lists Filaretos Bros Co. in Asminio, Istiaia, Greece. The listed products include refrigerated, ready-to-eat marinated anchovies in oil that are not thermally processed and ready-to-eat cold-smoked herring in vacuum packaging.

The public entry states that an FDA inspection found serious deviations from the seafood HACCP regulation in 21 CFR Part 123. FDA concluded that the listed seafood appeared adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act because it was prepared, packed, or held under conditions where it may have been contaminated or rendered injurious to health.

Which seafood HACCP controls did FDA question?

FDA identified an inadequate critical limit under 21 CFR 123.6(c)(3) and a failure to identify one or more necessary critical control points under 21 CFR 123.6(c)(2). Those are not paperwork-only details. A critical control point identifies where a significant hazard can be prevented, eliminated, or reduced, while a critical limit defines the measurable boundary that separates acceptable operation from a deviation.

Ready-to-eat refrigerated seafood deserves particular attention because consumers may eat it without a final cooking step. Marination, smoking, oil packing, refrigeration, and reduced-oxygen packaging each affect the hazard analysis, but none should be assumed to control every relevant biological hazard without scientific support and consistent monitoring.

What should seafood exporters verify before a US shipment?

• Prepare a product-specific hazard analysis instead of reusing one generic HACCP plan across different species, processes, and packaging formats.
• Identify every necessary critical control point from receiving through processing, cooling, packaging, storage, and shipment.
• Use critical limits that are measurable, scientifically supported, and matched to the hazard being controlled.
• Document monitoring, corrective actions, verification, calibration, and record review so the plan can be demonstrated in practice.
• Check FDA import alerts by legal manufacturer name and product description before loading the shipment.

Quick answers for Greek seafood exporters

Does FDA food facility registration prove seafood HACCP compliance?

No. Registration identifies the facility. It does not approve the facility, validate its HACCP plan, or prevent detention when FDA finds that listed products appear noncompliant.

Does an import alert mean FDA recalled these products?

No. This public record describes detention without physical examination for specified imports. An import alert and a market recall are different regulatory actions.

Verified public sources

• FDA Import Alert 16-120, including the Filaretos Bros Co. entry: https://www.accessdata.fda.gov/cms_ia/importalert_25.html
• FDA Fish and Fishery Products Hazards and Controls Guidance: https://www.fda.gov/food/seafood-guidance-documents-regulatory-information/fish-and-fishery-products-hazards-and-controls

FDABridge helps foreign seafood facilities review FDA registration, US Agent coverage, seafood HACCP records, labels, and import-alert exposure. Visit fdabridge.com/food or fdabridge.com/contact.