Sanlei (Pty) Ltd
FDA import alert and refusal historyKatse Village, LesothoFEI 3021993714
As of October 27, 2026, Sanlei (Pty) Ltd (Katse Village, Lesotho) is on the red list of FDA Import Alert 16-124 (Aquaculture seafood: unapproved drugs) for rainbow trout; steelhead trout; oncorhynchus mykiss, published by FDA on May 14, 2025, and has 2 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- IA 16-124 · red list
- Last import refusal
- Trout, all, aquaculture harvested fishery/seafood products · VETDRUGRES
- Last warning letter
- None found
- Last inspection
- Classified VAI (Voluntary Action Indicated)
Every FDA record for Sanlei (Pty) Ltd
4 records, newest first. Each line links to the FDA page it came from.
2026
- Import refusalSource
Refused, 2 lines in one entry: Trout, all, aquaculture harvested fishery/seafood productsVETDRUGRESEntry MH7-2118821-6Show 2 linesHide lines
- Refused, Trout, all, aquaculture harvested fishery/seafood productsVETDRUGRESEntry MH7-2118821-6Source
- Refused, Trout, all, aquaculture harvested fishery/seafood productsVETDRUGRESEntry MH7-2118821-6Source
2025
- Import alert listingListed on Import Alert 16-124red listRainbow Trout; Steelhead Trout; Oncorhynchus mykissSource
2024
- InspectionInspection classified VAI (Voluntary Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological HazardsSource
Refusal charges, in plain English
- VETDRUGRES2 refused lines
Animal drug residue
The product appeared to contain a new animal drug, or a conversion product of one, that is unsafe within the meaning of section 512 of the FD&C Act.
Questions about Sanlei (Pty) Ltd
- Is Sanlei (Pty) Ltd on an FDA import alert?
- Yes. As of October 27, 2026, Sanlei (Pty) Ltd is on the red list of FDA Import Alert 16-124, “Aquaculture seafood: unapproved drugs”, for rainbow trout; steelhead trout; oncorhynchus mykiss; FDA published the listing on May 14, 2025.
- Has FDA refused shipments from Sanlei (Pty) Ltd?
- Yes. FDA refused 2 shipment lines from Sanlei (Pty) Ltd on July 31, 2026. The most recent, on July 31, 2026, was trout, all, aquaculture harvested fishery/seafood products, charged as VETDRUGRES (animal drug residue).
- Why did FDA refuse Sanlei (Pty) Ltd's shipments?
- The most frequent charge is VETDRUGRES (animal drug residue, 2 lines).
- When was Sanlei (Pty) Ltd last inspected by FDA?
- FDA's most recent inspection of Sanlei (Pty) Ltd with a final classification is dated July 9, 2024 and was classified VAI (Voluntary Action Indicated).
- What is Sanlei (Pty) Ltd's FEI number?
- Sanlei (Pty) Ltd's FDA Establishment Identifier (FEI) is 3021993714.
- Can shipments from Sanlei (Pty) Ltd still enter the U.S.?
- Shipments of rainbow trout; steelhead trout; oncorhynchus mykiss from Sanlei (Pty) Ltd can be detained without physical examination under Import Alert 16-124; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).
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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.