Dabur India has received a warning letter from the U.S. Food and Drug Administration (USFDA) following an inspection of its manufacturing facility in Silvassa, where regulators identified significant violations related to current Good Manufacturing Practices (cGMP).
The warning letter, dated July 24, follows an earlier inspection by the USFDA. According to the regulator, the facility showed serious deficiencies involving data integrity, quality oversight, and manufacturing controls.
Key Findings by the USFDA
The USFDA highlighted several critical observations during its inspection, including:
- Data integrity lapses affecting manufacturing records.
- Inadequate quality oversight and deficient manufacturing controls.
- An equipment usage logbook was allegedly falsified, with several products marketed in the U.S. omitted from the original records.
- Incomplete laboratory documentation, including missing analytical records, testing procedures, workbooks, and data sheets for multiple batches of products intended for the U.S. market.
These findings raised concerns about the reliability of manufacturing and quality assurance processes at the inspected facility.
Dabur’s Response
Dabur acknowledged the observations and informed the regulator that it has initiated corrective measures, including:
- Retraining manufacturing and quality personnel.
- Strengthening documentation and record-keeping practices.
- Implementing corrective and preventive action (CAPA) plans to address the identified deficiencies.
However, according to the warning letter, the USFDA considered the company’s initial response inadequate and requested more comprehensive corrective actions.
Why It Matters
A USFDA warning letter is a significant regulatory action indicating that a manufacturer has not met required cGMP standards. If the identified issues are not adequately resolved, the company could face additional enforcement actions, including import restrictions or other regulatory measures affecting products intended for the U.S. market.
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