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Sanlei (Pty) Ltd

FDA import alert and refusal historyThabatseka, LesothoFEI 3031945833

Recorded by FDA as SANLEI (PTY) LTD

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

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As of October 25, 2026, Sanlei (Pty) Ltd (Thabatseka, 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 1 FDA import refusal recorded since October 2016.

Data from FDA public records, last checked . Request a correction

Current status

Last import refusal
Trout (rainbow, brook, brown, char, steelhead, etc.) · VETDRUGRES
Last warning letter
None found
Last inspection
None on record

Every FDA record for Sanlei (Pty) Ltd

2 records, newest first. Each line links to the FDA page it came from.

2025

  1. Import alert listing
    Listed on Import Alert 16-124red listRainbow Trout; Steelhead Trout; Oncorhynchus mykiss
    Source
  2. Import refusal
    Refused, Trout (rainbow, brook, brown, char, steelhead, etc.)VETDRUGRESEntry 788-1883556-9
    Source

Refusal charges, in plain English

  • VETDRUGRES1 refused line

    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 25, 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 1 shipment line from Sanlei (Pty) Ltd on May 14, 2025. The most recent, on May 14, 2025, was trout (rainbow, brook, brown, char, steelhead, etc.), charged as VETDRUGRES (animal drug residue).
Why did FDA refuse Sanlei (Pty) Ltd's shipments?
The most frequent charge is VETDRUGRES (animal drug residue, 1 line).
What is Sanlei (Pty) Ltd's FEI number?
Sanlei (Pty) Ltd's FDA Establishment Identifier (FEI) is 3031945833.
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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Example subjectSanlei (Pty) Lt added to Import Alert 16-129 (red list)

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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.