# Empacadora Lota Seafoods S.A. · 16-120 · CHILE — FDA import alert red lists: firms subject to detention without physical examination

For Empacadora Lota Seafoods S.A. · 16-120 · CHILE, import alert is 16-120; import alert name is "Detention Without Physical Examination of ***Fish and Fishery*** Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP ***Regulation***"; country is CHILE; product is All histamine forming species seafood; specifically frozen; raw; vacuum packed/ROP; wild caught Swordfish head gut tail (HGT); and loin; product code is 16 A - - -- Fish; date published is 02/27/2026; address is Parque Industrial, Lote 13 Y 14 , Lota, Region del Bio-Bio CHILE, verified against its source on 2026-09-16.

- **Firm:** Empacadora Lota Seafoods S.A. _(verified: appears in the quote below)_
- **Import alert:** 16-120
- **Import alert name:** "Detention Without Physical Examination of ***Fish and Fishery*** Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP ***Regulation***"
- **Country:** CHILE _(verified: appears in the quote below)_
- **Address:** Parque Industrial, Lote 13 Y 14 , Lota, Region del Bio-Bio CHILE _(verified: appears in the quote below)_
- **Date published:** 02/27/2026 _(verified: appears in the quote below)_
- **Product code:** 16 A - - -- Fish _(verified: appears in the quote below)_
- **Product:** All histamine forming species seafood; specifically frozen; raw; vacuum packed/ROP; wild caught Swordfish head gut tail (HGT); and loin _(verified: appears in the quote below)_
- **FDA notes:** FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings and review of the firm’s response, the FDA determined that the firm’s histamine forming species such as frozen, raw, vacuum-packed, wild caught Swordfish head-gut-tail (HGT) and loin seafood products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), failure to identify hazards likely to occur; 21 CFR 123.6(c)(3), inadequate critical limit; and 21 CFR 123.6(c)(4), inadequate monitoring procedures. _(verified: appears in the quote below)_

## What the source says

> Empacadora Lota Seafoods S.A. Date Published : 02/27/2026 Parque Industrial, Lote 13 Y 14 , Lota, Region del Bio-Bio CHILE 16 A - - -- Fish Date Published: 02/27/2026 Desc: All histamine forming species seafood; specifically frozen; raw; vacuum packed/ROP; wild caught Swordfish head gut tail (HGT); and loin Notes: FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA’s inspectional findings and review of the firm’s response, the FDA determined that the firm’s histamine forming species such as frozen, raw, vacuum-packed, wild caught Swordfish head-gut-tail (HGT) and loin seafood products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), failure to identify hazards likely to occur; 21 CFR 123.6(c)(3), inadequate critical limit; and 21 CFR 123.6(c)(4), inadequate monitoring procedures.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_25.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).