USFDA cGMP inspection at SEZ II, Ahmedabad plant closes with one observation

USFDA completed a cGMP inspection of the SEZ II, Ahmedabad plant from 21st to 28th September 2026.

Mon 28 Sep 2026

Inspection Period

21st to 28th September 2026

Inspection Outcome

Closed with one observation

Data Integrity Issues

No data integrity related observations

What happened

The US Food and Drug Administration carried out a current Good Manufacturing Practice (cGMP) inspection at the company's manufacturing plant at SEZ II, Ahmedabad. The inspection ran from 21st to 28th September 2026.

Outcome

• The inspection closed with one observation.
• There were no data integrity related observations.
• The company will work closely with the USFDA to address the observation expeditiously.

Why it matters

USFDA inspections check whether a plant follows US manufacturing quality standards, which matters for plants supplying medicines to the US market. Observations are noted by inspectors when they see practices needing correction. A single observation, with no data integrity issues flagged, is generally seen as a limited outcome compared with a longer list of findings.

What to watch

• How the observation is classified by the USFDA and the agency's follow-up communication.
• The company's response and closure of the observation.

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