Warning letterPosted August 4, 2026

FDA warning letter to Dabur India Limited

CGMP/Finished Pharmaceuticals/Adulterated

FDA's record ↗

FDA posted a warning letter to Dabur India Limited on August 4, 2026; the letter is dated July 24, 2026. Subject: CGMP/Finished Pharmaceuticals/Adulterated. Issuing office: Center for Drug Evaluation and Research (CDER).

On the record

Company
Dabur India Limited
Subject
CGMP/Finished Pharmaceuticals/Adulterated
Issuing office
Center for Drug Evaluation and Research (CDER)
Letter dated
2026-07-24
Posted by FDA
2026-08-04
Source
FDA warning letters ↗

CFR cited

The record cites 4 sections of 21 CFR Parts 210 and 211.

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.

More

Watch Dabur India Limited

A free account shows the last 7 days of every FDA, SEC and ClinicalTrials.gov source. Pro adds a watchlist: one email when FDA acts on a company you name.

From FDA warning letters. The record may have changed since it was read.

Approve Suite is not affiliated with FDA, or with Dabur India Limited. Informational only.

See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.