SupplierRadar

Sanlei (Pty) Ltd

FDA import alert and refusal historyKatse Village, LesothoFEI 3021993714

Watch this supplier

Watch this supplier

Get an email when FDA publishes anything new on Sanlei (Pty) Ltd.

Enter your work email and confirm with the link we send. Your first supplier is free, with no password and no card.

Example subjectSanlei (Pty) Lt added to Import Alert 16-129 (red list)

Free for one supplier. No password, no card.

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

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

  1. Import refusal
    Refused, 2 lines in one entry: Trout, all, aquaculture harvested fishery/seafood productsVETDRUGRESEntry MH7-2118821-6Show 2 lines
    • Refused, Trout, all, aquaculture harvested fishery/seafood productsVETDRUGRESEntry MH7-2118821-6Source
    • Refused, Trout, all, aquaculture harvested fishery/seafood productsVETDRUGRESEntry MH7-2118821-6Source
    Source

2025

  1. Import alert listing
    Listed on Import Alert 16-124red listRainbow Trout; Steelhead Trout; Oncorhynchus mykiss
    Source

2024

  1. Inspection
    Inspection classified VAI (Voluntary Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards
    Source

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).

Buying from Sanlei (Pty) Ltd?

Watch it and get the FDA record the day it changes. Free for one supplier.

Watch this supplier

Watch this supplier

Get an email when FDA publishes anything new on Sanlei (Pty) Ltd.

Enter your work email and confirm with the link we send. Your first supplier is free, with no password and no card.

Example subjectSanlei (Pty) Lt added to Import Alert 16-129 (red list)

Free for one supplier. No password, no card.

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.