FDA Stories #030 — A Chilean Swordfish Processor Reached FDA's Seafood HACCP Detention List

Short answer: FDA placed specified frozen, raw, vacuum-packed swordfish from Empacadora Lota Seafoods S.A. in Chile on Import Alert 16-120 after an inspection found serious seafood HACCP deviations. The listed products include wild-caught swordfish head-gut-tail and loins.

This article summarizes a public FDA import-alert entry published February 27, 2026. The company named in the record is not identified as an FDABridge client, and FDA's entry does not report a recall or illnesses.

What did FDA find at the Chilean seafood facility?

The alert states that FDA inspected the manufacturing facility and reviewed the firm's response. FDA then determined that the listed histamine-forming seafood products appeared adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act because they were processed under conditions where they may have been contaminated or rendered injurious to health.

FDA identified three categories of seafood HACCP deviations: failure to identify hazards reasonably likely to occur under 21 CFR 123.6(c)(1), an inadequate critical limit under 21 CFR 123.6(c)(3), and inadequate monitoring procedures under 21 CFR 123.6(c)(4). Together, those findings go to the core design and execution of a HACCP plan.

Why are swordfish time and temperature controls important?

Swordfish is a histamine-forming species. If time and temperature are not controlled after harvest, bacteria can convert naturally occurring histidine into histamine. Cooking or freezing does not reliably remove histamine once it has formed, so prevention depends on controls from the vessel and receiving step through processing, storage, and transport.

A plan must connect the identified hazard to operational controls. That means critical limits must be scientifically appropriate, monitoring must be frequent and reliable enough to show the limit was met, and records must let a reviewer determine what happened to the actual lot. A generic statement such as 'keep frozen' does not substitute for a complete hazard-control system.

What should Chilean fish exporters document?

• Identify species-specific hazards and assess each product form, including raw, frozen, loin, HGT, and reduced-oxygen packaging.
• Define receiving controls using appropriate harvest-vessel records, sensory examination, internal temperatures, ice condition, or testing as justified by FDA guidance.
• Set measurable critical limits and monitoring frequencies that cover the full lot rather than an informal spot check.
• Document corrective action for both the affected product and the cause of each process deviation.
• Align the foreign processor's records with the US importer's seafood HACCP affirmative-step obligations.

Quick answers for Chilean seafood exporters

Does freezing destroy histamine already formed in swordfish?

No. Freezing can control further bacterial growth, but it does not reliably eliminate histamine that formed before the fish was frozen.

Is a written HACCP plan enough to avoid detention?

No. The plan must identify the relevant hazards and contain adequate critical limits, monitoring, corrective actions, verification, and records that are implemented in daily production.

Verified public sources

• FDA Import Alert 16-120, including the Empacadora Lota Seafoods 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 supports seafood facilities with FDA registration, US Agent service, HACCP readiness, label review, and import-alert checks. Visit fdabridge.com/food or fdabridge.com/contact.