# REAL CONSERVERA ESPANOLA, S.L. · 16-120 · SPAIN — FDA import alert red lists: firms subject to detention without physical examination

For REAL CONSERVERA ESPANOLA, S.L. · 16-120 · SPAIN, 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 SPAIN; product is Low acid canned Mackerel; Spanish or King | Low acid canned Sardines | Low acid canned Mackerel | Low acid canned Gar | Low acid canned Sardines; Cold Smoked; product code is 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King) | 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.) | 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22') | 16 A - - 99 Fish, N.E.C. | 16 S - - 33 Sardines (Brisling, Sprats, Pilchards, etc.), Cold Smoked, Fish; date published is 01/06/2026; address is Poligono Industrial Sete Pias No. 30 , Cambados , Pontevedra, Galicia SPAIN, verified against its source on 2026-09-16.

- **Firm:** REAL CONSERVERA ESPANOLA, S.L. _(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:** SPAIN _(verified: appears in the quote below)_
- **Address:** Poligono Industrial Sete Pias No. 30 , Cambados , Pontevedra, Galicia SPAIN _(verified: appears in the quote below)_
- **Date published:** 01/06/2026 _(verified: appears in the quote below)_
- **Product code:** 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King) | 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.) | 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22') | 16 A - - 99 Fish, N.E.C. | 16 S - - 33 Sardines (Brisling, Sprats, Pilchards, etc.), Cold Smoked, Fish _(verified: each item appears in the quote below)_
- **Product:** Low acid canned Mackerel; Spanish or King | Low acid canned Sardines | Low acid canned Mackerel | Low acid canned Gar | Low acid canned Sardines; Cold Smoked _(verified: each item appears in the quote below)_
- **FDA notes:** A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA’s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (“Act”), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) – Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) – Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions. | A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA’s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (“Act”), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) – Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) – Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions. | A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA’s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (“Act”), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) – Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) – Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions. | A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA’s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (“Act”), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) – Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) – Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions. | A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA’s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (“Act”), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) – Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) – Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions. _(verified: each item appears in the quote below)_

## What the source says

> REAL CONSERVERA ESPANOLA, S.L. Date Published : 01/06/2026 Poligono Industrial Sete Pias No. 30 , Cambados , Pontevedra, Galicia SPAIN 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King) Date Published: 01/06/2026 Desc: Low acid canned Mackerel; Spanish or King Notes: A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA’s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (“Act”), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) – Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) – Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions. 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.) Date Published: 01/06/2026 Desc: Low acid canned Sardines Notes: A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA’s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (“Act”), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) – Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) – Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions. 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22') Date Published: 01/06/2026 Desc: Low acid canned Mackerel Notes: A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA’s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (“Act”), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) – Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) – Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions. 16 A - - 99 Fish, N.E.C. Date Published: 01/06/2026 Desc: Low acid canned Gar Notes: A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA’s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (“Act”), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) – Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) – Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions. 16 S - - 33 Sardines (Brisling, Sprats, Pilchards, etc.), Cold Smoked, Fish Date Published: 01/06/2026 Desc: Low acid canned Sardines; Cold Smoked Notes: A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA’s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (“Act”), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) – Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) – Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions.

## 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/).