Reference Source

Grupo VPAS C.A. · 16-120 · VENEZUELA

For Grupo VPAS C.A. · 16-120 · VENEZUELA, 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 VENEZUELA; product is IQF Medregal fillet with skin and without skin; Medregal; Seriola dumerili; Greater Amberjack; Yellowtail | IQF Medregal fillet with skin and without skin; Medregal; Seriola dumerili; Greater Amberjack; Yellowtail | IQF Medregal fillet with skin and without skin; Medregal; Seriola dumerili; Greater Amberjack; Yellowtail; product code is 16 A - - 37 Snapper (Red, Gray, Malabar, etc.) | 16 A - - 79 Yellowtail, Amberjack | 16 - - - -- Fishery/Seafood Products; date published is 09/10/2025; address is Urb. Los Ruices Sur , Trieste Local Galpon S/N , Caracas, Miranda VENEZUELA, verified against its source on 2026-09-16.

Firm
Grupo VPAS C.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
VENEZUELA verified
Address
Urb. Los Ruices Sur , Trieste Local Galpon S/N , Caracas, Miranda VENEZUELA verified
Date published
09/10/2025 verified
Product code
16 A - - 37 Snapper (Red, Gray, Malabar, etc.) | 16 A - - 79 Yellowtail, Amberjack | 16 - - - -- Fishery/Seafood Products each item verified
Product
IQF Medregal fillet with skin and without skin; Medregal; Seriola dumerili; Greater Amberjack; Yellowtail | IQF Medregal fillet with skin and without skin; Medregal; Seriola dumerili; Greater Amberjack; Yellowtail | IQF Medregal fillet with skin and without skin; Medregal; Seriola dumerili; Greater Amberjack; Yellowtail each item verified
FDA notes
Medregal, Seriola dumerili, is known as Greater Amberjack, Yellowtail. Problem(s): FDA conducted a Foreign Remote Regulatory Assessment, of this food manufacturing facility and found serious deviations of the Seafood HACCP regulations (21 CFR Part 123). On October 17, 2024, the firm was issued an FDA Warning Letter. Based on FDA’s inspectional findings and review of the firm responses, we have determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(4)]. Specific violations include: 21 CFR 123.6(c)(3) – The critical limits are either not listed in the plan or are inadequate; 123.6(c)(2) – Critical control points are not listed in the HACCP plan; 21 CFR 123.6(c)(4) – Monitoring procedures are either not listed or inadequate. | Medregal, Seriola dumerili, is known as Greater Amberjack, Yellowtail. Problem(s): FDA conducted a Foreign Remote Regulatory Assessment, of this food manufacturing facility and found serious deviations of the Seafood HACCP regulations (21 CFR Part 123). On October 17, 2024, the firm was issued an FDA Warning Letter. Based on FDA’s inspectional findings and review of the firm responses, we have determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(4)]. Specific violations include: 21 CFR 123.6(c)(3) – The critical limits are either not listed in the plan or are inadequate; 123.6(c)(2) – Critical control points are not listed in the HACCP plan; 21 CFR 123.6(c)(4) – Monitoring procedures are either not listed or inadequate. | Medregal, Seriola dumerili, is known as Greater Amberjack, Yellowtail. Problem(s): FDA conducted a Foreign Remote Regulatory Assessment, of this food manufacturing facility and found serious deviations of the Seafood HACCP regulations (21 CFR Part 123). On October 17, 2024, the firm was issued an FDA Warning Letter. Based on FDA’s inspectional findings and review of the firm responses, we have determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(4)]. Specific violations include: 21 CFR 123.6(c)(3) – The critical limits are either not listed in the plan or are inadequate; 123.6(c)(2) – Critical control points are not listed in the HACCP plan; 21 CFR 123.6(c)(4) – Monitoring procedures are either not listed or inadequate. each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Grupo VPAS C.A. Date Published : 09/10/2025 Urb. Los Ruices Sur , Trieste Local Galpon S/N , Caracas, Miranda VENEZUELA 16 A - - 37 Snapper (Red, Gray, Malabar, etc.) Date Published: 09/10/2025 Desc: IQF Medregal fillet with skin and without skin; Medregal; Seriola dumerili; Greater Amberjack; Yellowtail Notes: Medregal, Seriola dumerili, is known as Greater Amberjack, Yellowtail. Problem(s): FDA conducted a Foreign Remote Regulatory Assessment, of this food manufacturing facility and found serious deviations of the Seafood HACCP regulations (21 CFR Part 123). On October 17, 2024, the firm was issued an FDA Warning Letter. Based on FDA’s inspectional findings and review of the firm responses, we have determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(4)]. Specific violations include: 21 CFR 123.6(c)(3) – The critical limits are either not listed in the plan or are inadequate; 123.6(c)(2) – Critical control points are not listed in the HACCP plan; 21 CFR 123.6(c)(4) – Monitoring procedures are either not listed or inadequate. 16 A - - 79 Yellowtail, Amberjack Date Published: 09/10/2025 Desc: IQF Medregal fillet with skin and without skin; Medregal; Seriola dumerili; Greater Amberjack; Yellowtail Notes: Medregal, Seriola dumerili, is known as Greater Amberjack, Yellowtail. Problem(s): FDA conducted a Foreign Remote Regulatory Assessment, of this food manufacturing facility and found serious deviations of the Seafood HACCP regulations (21 CFR Part 123). On October 17, 2024, the firm was issued an FDA Warning Letter. Based on FDA’s inspectional findings and review of the firm responses, we have determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(4)]. Specific violations include: 21 CFR 123.6(c)(3) – The critical limits are either not listed in the plan or are inadequate; 123.6(c)(2) – Critical control points are not listed in the HACCP plan; 21 CFR 123.6(c)(4) – Monitoring procedures are either not listed or inadequate. 16 - - - -- Fishery/Seafood Products Date Published: 09/10/2025 Desc: IQF Medregal fillet with skin and without skin; Medregal; Seriola dumerili; Greater Amberjack; Yellowtail Notes: Medregal, Seriola dumerili, is known as Greater Amberjack, Yellowtail. Problem(s): FDA conducted a Foreign Remote Regulatory Assessment, of this food manufacturing facility and found serious deviations of the Seafood HACCP regulations (21 CFR Part 123). On October 17, 2024, the firm was issued an FDA Warning Letter. Based on FDA’s inspectional findings and review of the firm responses, we have determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(4)]. Specific violations include: 21 CFR 123.6(c)(3) – The critical limits are either not listed in the plan or are inadequate; 123.6(c)(2) – Critical control points are not listed in the HACCP plan; 21 CFR 123.6(c)(4) – Monitoring procedures are either not listed or inadequate.

accessdata.fda.gov, retrieved 2026-09-01

Source

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