Import Alert 16-05: Detention without physical examination of mahimahi from Ecuador and Taiwan due to histamine and decomposition
As of October 26, 2026, FDA Import Alert 16-05 (Mahimahi from Ecuador and Taiwan: histamine, decomposition) lists 100 firms on its green list in 2 countries, covering mahi-mahi raw, fresh or frozen, including all product types/forms; 0 firms were added and 0 removed in the last 90 days.
Data from FDA public records, last checked . Request a correction
- 100
- firms on the green list
- 2
- countries
- 0
- added in the last 90 days
- 0
- removed in the last 90 days
What changed in the last 90 days
Removed from Import Alert 16-05
SupplierRadar has recorded no removals from Import Alert 16-05 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page, and on the firm's own page, the day it is found.
Added to Import Alert 16-05
No firm was added to Import Alert 16-05 in the last 90 days, as of October 26, 2026.
Firms on Import Alert 16-05, by country
Ecuador (76)
FDA refusals from Ecuador| Firm | List | Products | Date published |
|---|---|---|---|
| Agrol S.A.Manta | Green | Mahi Mahi | |
| Alra ExportSalinas | Green | Mahi Mahi | |
| Bajespec, S. A.Salinas | Green | Mahi Mahi | |
| Boris Buenaventura TrujilloManta | Green | Mahi Mahi | |
| Brimon S.A.Guayaquil | Green | Mahi Mahi | |
| CeproFish S.A.Guayaquil | Green | Mahi Mahi | |
| Cepromar S.A.Guayaquil | Green | Mahi Mahi | |
| Comercial Santana CedenoManta | Green | Mahi Mahi | |
| Conservas Marinas, S AEsmeraldas | Green | Mahi Mahi | |
| Costapesca, CIA. LTDAQuito | Green | Mahi Mahi | |
| Criaderos Acuaticos La GuitaGuayaquil | Green | Mahi Mahi | |
| DimaworkGuayaquil | Green | Mahi Mahi | |
| Docapes Pescados Camarones y Mariscos S.A.El Malecon De Santa Rosa Salinas | Green | Mahi Mahi | |
| Ecuador Mar Fishing Co. EmarfisaGuayaquil | Green | Mahi Mahi | |
| Ecuafish S.A.ESMERALDAS | Green | Mahi Mahi | |
| Ecuafresco SA PlantaManta | Green | Mahi Mahi | |
| Ecuamar S AGuayaquil | Green | Mahi Mahi | |
| el rosario ersa s.a.Guayaquil | Green | Mahi Mahi | |
| Empacadora Bilbo S.A.Montecristi | Green | Mahi Mahi | |
| Empacadora Coral del Pacifico EMCOPAC S.A.Esmeraldas | Green | Mahi Mahi | |
| Empacadora DiamanteESMERALDAS | Green | Mahi Mahi | |
| Escualem S.A.Guayaquil | Green | Mahi Mahi | |
| Exportadora Del Oceano Pacifico OceanpacGuayaquil | Green | Mahi Mahi | |
| Exportadora GamexCorretero Monta | Green | Mahi Mahi | |
| Exportadora Yifar Express Sudamerica S A EmpacadoraGuayaquil | Green | Mahi Mahi |
Show 51 more firms in Ecuador
| Firm | List | Products | Date published |
|---|---|---|---|
| Expotuna S.A.Guayaquil | Green | Mahi Mahi | |
| FishcorpJaramijo | Green | Mahi Mahi | |
| Fortumar Ecuador S AGuayaquil | Green | Mahi Mahi | |
| Fresh Fish del Ecuador Cia., Ltda.Manta | Green | Mahi Mahi | |
| Frigolab San Mateo Cia. LtdaJaramigo | Green | Mahi Mahi | |
| Frigolandia, SAGuayaquil | Green | Mahi Mahi | |
| Frigorifico y LaboratorioJaramijo | Green | Mahi Mahi | |
| Frigorificos Acuario S A (FRACUSA)Guayaquil | Green | Mahi Mahi | |
| Frigorificos Y Conservas Narinas (Fricomsa)Guayaquil | Green | Mahi Mahi | |
| Frio y Mariscos Cia. Ltda. FrimarGuayaquil | Green | Mahi Mahi | |
| Frumaco S AGuayaquil | Green | Mahi Mahi | |
| Gambas del Pacifico S.A.Guayaquil | Green | Mahi Mahi | |
| Gondi S.A.Portoviejo | Green | Mahi Mahi | |
| Good FishQuito | Green | Mahi Mahi | |
| GrumodusGuayaquil | Green | Mahi Mahi | |
| Grupo Degfer Cia LtdaManta | Green | Mahi Mahi | |
| Hantamar S.A.Guayaquil | Green | Mahi Mahi | |
| Henmor S.A.Manta | Green | Mahi Mahi | |
| Industria Exportadora Del Pacifico Cia LtdaGuayaquil | Green | Mahi Mahi | |
| Industrial Pesquera Monteverde C A (INPECA)Guayaquil | Green | Mahi Mahi | |
| Industrias Del Mar Lubar Cia LtdManta | Green | Mahi Mahi | |
| Julieta MeraGuayaquil | Green | Mahi Mahi | |
| Mahi Mahi EcuadorQuito | Green | Mahi Mahi | |
| Makaira A.C.PGuayaquil | Green | Mahi Mahi | |
| Mardelit Cia LtdaManta | Green | Mahi Mahi | |
| Mariscos de Chupadores Chupamar S.A.Guayaquil | Green | Mahi Mahi | |
| Mariscos Y Crustaceos (Marcrusa)Guayaquil | Green | Mahi Mahi | |
| Natural Select S.a.Guayaquil | Green | Mahi Mahi | |
| Negocios Industriales Real S-.A (Nirsa)Guayaquil | Green | Mahi Mahi | |
| Neptuna CIA LtdaGuayaquil | Green | Mahi Mahi | |
| Ocean Fish, S.A.Manta | Green | Mahi Mahi | |
| P.A.B. SeafoodQuito | Green | Mahi Mahi | |
| Pacific Fish S.C.C.Quito | Green | Mahi Mahi | |
| Paexport S AGuayaquil | Green | Mahi Mahi | |
| Patricio Villamar/ Agroseafood S.A.Guayaquil | Green | Mahi Mahi | |
| PCC Congelados & Frescos S.A.Huaquillas | Green | Mahi Mahi | |
| Pefresco MarManta | Green | Mahi Mahi | |
| Pefresman Cia LtdaManta | Green | Mahi Mahi | |
| Pesca Ecuatoriana Cia LtdaManta | Green | Mahi Mahi | |
| Pesnusan Cia LtdaManta | Green | Mahi Mahi | |
| Pesquera Progalca C.A.Guayaquil | Green | Mahi Mahi | |
| Phillips Seafood Ecuador, CAGuayaquil | Green | Mahi Mahi | |
| Promarosa Productos Del Mar Ltda.Salinas | Green | Mahi Mahi | |
| Promarpasa Productos Del Mar PaticosGuayaquil | Green | Mahi Mahi | |
| Propemar S.A.Montecristi | Green | Mahi Mahi | |
| Rader SaGuayaquil | Green | Mahi Mahi | |
| Sandra Ronquillo PerezSalinas | Green | Mahi Mahi | |
| Super Fresco SeafoodQuito | Green | Mahi Mahi | |
| Transmarina C.A.Montecristi | Green | Mahi Mahi | |
| Trife F Fresh Fishes Finest S.AGuayaquil | Green | Mahi Mahi | |
| Yes Fish.S.AJaramijo | Green | Mahi Mahi |
Taiwan (24)
FDA refusals from TaiwanRefusal charges named on this alert
What the alert covers and why FDA issued it
- Official title
- Detention Without Physical Examination of Mahimahi from Ecuador and Taiwan Due to Histamine and Decomposition
- Product scope
- Mahi-mahi (Coryphaena spp.,dolphin, dolphinfish) raw, fresh or frozen, including all product types/forms
- Last published
In March 1980, the Center for Disease Control reported that mahi-mahi (dolphin fish) accounted for 40% of the scombrotoxin-fish poisoning (SFP) outbreaks reported in the United States.
Also, during March 1980, FDA received reports of 10 separate scombrotoxin-fish poisoning incidents involving about 70 people. As a result, on April 28, 1980, the districts were instructed to sample and analyze, for histamine, 100% of all shipments of mahi-mahi offered for entry from all countries.
Read the rest of the reason
On July 8, 1980, the districts reported that they sampled and analyzed 73 shipments of mahi-mahi from China, Ecuador, Peru, and Taiwan. From this data, it was determined that all shipments of mahi-mahi from Ecuador and Taiwan met the criteria for detention without physical examination (DWPE).
In the latter part of FY 80, LOS-DO organoleptically detected decomposition in 11 of 24 (46%) of mahi-mahi samples from Ecuador and Taiwan. Mahi-mahi may be decomposed without toxicologically significant levels of histamine. Thus, all Division import personnel must be alert to the possibility of significant decomposition problems in mahi-mahi, even when toxicologically significant histamine levels are not noted.
Odors of spoilage are not necessarily found in the same part of fish where histamine is found.
Sample results as well as a number of reported illnesses attributed to imported mahi-mahi indicate continuing problems with histamines and decomposition in mahi-mahi from Ecuador.
Listing on an import alert is FDA's notice to the firm and a fact an importer must consider in its supplier evaluation under 21 CFR 1.505. What the red, green and yellow lists mean.
Questions about Import Alert 16-05
- What is Import Alert 16-05?
- Import Alert 16-05, “Detention without physical examination of mahimahi from Ecuador and Taiwan due to histamine and decomposition”, is an FDA import alert. Its listed firms are on the green list, which exempts their listed products from detention without physical examination under that alert; FDA last published the alert on July 28, 2025.
- Which firms are on Import Alert 16-05?
- As of October 26, 2026, 100 firms are listed on Import Alert 16-05 in 2 countries; the most listings are in Ecuador (76) and Taiwan (24). The full table, grouped by country, is below on this page and every firm links to its record.
- How do firms get off Import Alert 16-05?
- A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 16-05; our guide explains the steps and the evidence FDA usually asks for.
- What charge does FDA use under Import Alert 16-05?
- The charge section of Import Alert 16-05 names FILTHY (filthy, putrid or decomposed substance) and POISONORD (poisonous or deleterious substance (ordinarily injurious)). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.
- Which firms were added to Import Alert 16-05 recently?
- No firm was added to Import Alert 16-05 in the last 90 days, as of October 26, 2026.
- Which firms were removed from Import Alert 16-05 recently?
- SupplierRadar has recorded no removals from Import Alert 16-05 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page and on the firm's page the day it is found.
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