Warning letterPosted December 30, 2025

FDA warning letter to Palamur Biosciences Private Limited

Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies

FDA's record ↗

FDA posted a warning letter to Palamur Biosciences Private Limited on December 30, 2025; the letter is dated December 11, 2025. Subject: Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. Issuing office: Center for Devices and Radiological Health.

On the record

Company
Palamur Biosciences Private Limited
Subject
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Issuing office
Center for Devices and Radiological Health
Letter dated
2025-12-11
Posted by FDA
2025-12-30
Source
FDA warning letters ↗

CFR cited

The record cites 5 sections of 21 CFR Part 58.

The full record

An account shows the violations FDA described and each CFR section it cited.

What a warning letter is

A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.

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