Empacadora Lota Seafoods S.A. · 16-120 · CHILE
For Empacadora Lota Seafoods S.A., import alert is 16-120; country is CHILE; import alert name is "Detention Without Physical Examination of ***Fish and Fishery*** Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP ***Regulation***"; 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 2026-09-30.
- Firm
- Empacadora Lota Seafoods S.A. verified
- 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
- Address
- Parque Industrial, Lote 13 Y 14 , Lota, Region del Bio-Bio CHILE verified
- Date published
- 02/27/2026 verified
- Product code
- 16 A - - -- Fish verified
- Product
- All histamine forming species seafood; specifically frozen; raw; vacuum packed/ROP; wild caught Swordfish head gut tail (HGT); and loin verified
- 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
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
— accessdata.fda.gov, retrieved 2026-09-01
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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.
— all from accessdata.fda.gov, retrieved 2026-09-01
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_25.html