Import Alert 16-127: Detention without physical examination of all seafood due to chloramphenicol
As of October 25, 2026, FDA Import Alert 16-127 (Seafood: chloramphenicol) lists 73 firms on its red list in 7 countries, covering all seafood; 1 firm was added and 0 removed in the last 90 days.
Data from FDA public records, last checked . Request a correction
- 73
- firms on the red list
- 7
- countries
- 1
- added in the last 90 days
- 0
- removed in the last 90 days
What changed in the last 90 days
Removed from Import Alert 16-127
SupplierRadar has recorded no removals from Import Alert 16-127 in the last 90 days, as of October 25, 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 16-127
| Firm | Country | List | Date published |
|---|---|---|---|
| PT. Winaros Kawula BahariPasuruan, Indonesia | Indonesia | Red |
Firms on Import Alert 16-127, by country
Listings by country
China (23)
FDA refusals from ChinaVietnam (23)
FDA refusals from VietnamIndonesia (12)
FDA refusals from Indonesia| Firm | List | Products | Date published |
|---|---|---|---|
| CV. Sira Guna PutraMedan | Red | Crab | |
| Pt Rajungan Sapta NusaKabupaten | Red | Crabmeat | |
| Pt. Mina Global MandiriPurwakarta | Red | Crabmeat | |
| PT. Panji Saburai PutraBandarlampung | Red | Crab | |
| PT. Tonga Tiur PutraRembang | Red | Crabmeat | |
| PT. Tonga Tiur PutraTarakan | Red | Crab Meat | |
| PT. Tonga Tiur PutraCirebon | Red | Crabmeat | |
| PT. Tonga Tiur PutraBandar Lampung | Red | Crabmeat | |
| PT. Winaros Kawula BahariPasuruan | Red | All Shrimp, Cooked and Raw | |
| PT. Windika UtamaSemarang | Red | Crabmeat | |
| Pttrans Seafood IndustryMedan | Red | Crabmeat | |
| Tonga Tiur Putra PJakarta | Red | Crab Meat |
Malaysia (11)
FDA refusals from Malaysia| Firm | List | Products | Date published |
|---|---|---|---|
| CAB Food Sdn. Bhd.Seberang Jaya Perai | Red | Shrimp | |
| Cab Marine Resources Sdn. Bhd.Nibong Tebal | Red | Shrimp | |
| Globe Season EnterpriseBarat Daya | Red | Shrimp | |
| Hong San Frozen Foods Sdn BhdSeberang Perai Utara | Red | Shrimp | |
| Lean Heng Huat FisherySeberang Perai Tengah | Red | Shrimp | |
| Mutiara Seafood ExporterBukit Mertajam | Red | Shrimp | |
| N.T. Huat Kee Fisheries SDN. BHD.Pinang | Red | Shrimp | |
| Seiko Marine Products Sdn BhdKlang, Selangor | Red | Shrimp | |
| Seng Enterprise Seafood Supplier (1986)George Town | Red | Shrimp | |
| Soonfroze Corporation Sdn BhdBagan Serai | Red | Shrimp | |
| Straits Sea Foods Trading Co. Sdn.Bhd.Sarikei | Red | Shrimp |
Venezuela (2)
FDA refusals from Venezuela| Firm | List | Products | Date published |
|---|---|---|---|
| Procesadora "El Cangrejito del Mar" C.A. (Procamar, C.A.)Concepcion | Red | Crabmeat | |
| Productora De Alimentos Del Lago C.A.Maracaibo | Red | Crab |
Brazil (1)
FDA refusals from Brazil| Firm | List | Products | Date published |
|---|---|---|---|
| Juncao Inc. Com. De Pescados Ltda.Rio Grande | Red | Crab |
Mexico (1)
FDA refusals from Mexico| Firm | List | Products | Date published |
|---|---|---|---|
| Procesadora de Mariscos America, SA de CVMatamoros | Red | Crab Meat |
Refusal charges named on this alert
| Charge code | Meaning | Refusal lines since 2016 |
|---|---|---|
| POIS CHLOR | The article appears to contain a poisonous or deleterious substance, namely chloramphenicol, which may… | 48 |
| CHLORAMP | The article appears to contain a food additive, namely chloramphenicol, that is unsafe within the meaning of… | 45 |
What the alert covers and why FDA issued it
- Official title
- Detention Without Physical Examination of All Seafood Due to Chloramphenicol
- Product scope
- All Seafood
- Last published
Chloramphenicol is a broad-spectrum antibiotic that is not approved for use in food producing animals and has been prohibited from extra-label uses in food producing animals in the United States (U.S.).
Use of the antibiotic in humans, in the U.S., is reserved for treatment of certain serious, potentially life-threatening infections. Therapeutic doses correlate with a low incidence (1:30,000 to 1:50,000) of serious and potentially fatal blood disorders, such as idiosyncratic aplastic anemia.
Read the rest of the reason
Since these adverse reactions are idiosyncratic and are not dose related, a safe level of exposure to chloramphenicol has yet to be determined.
Chloramphenicol is suspected to be a carcinogen and potentially affect the reproductive system in humans.
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 16-127
- What is Import Alert 16-127?
- Import Alert 16-127, “Detention without physical examination of all seafood due to chloramphenicol”, is an FDA import alert. FDA may detain all seafood from the firms on its red list without physical examination; FDA last published the alert on October 13, 2026.
- Which firms are on Import Alert 16-127?
- As of October 25, 2026, 73 firms are listed on Import Alert 16-127 in 7 countries; the most listings are in China (23), Vietnam (23) and Indonesia (12). 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 16-127?
- 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 16-127; our guide explains the steps and the evidence FDA usually asks for.
- What charge does FDA use under Import Alert 16-127?
- The charge section of Import Alert 16-127 names POIS CHLOR (the article appears to contain a poisonous or deleterious substance, namely chloramphenicol, which may…) and CHLORAMP (the article appears to contain a food additive, namely chloramphenicol, that is unsafe within the meaning of…). 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 16-127 recently?
- As of October 25, 2026, 1 firm was added to Import Alert 16-127 in the last 90 days, including PT. Winaros Kawula Bahari. The list with dates is below.
- Which firms were removed from Import Alert 16-127 recently?
- SupplierRadar has recorded no removals from Import Alert 16-127 in the last 90 days, as of October 25, 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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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.