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Zydus Ahmedabad Plant Receives One USFDA Inspection Observation
Zydus Lifesciences has a manufacturing plant in Ahmedabad.
The US health regulator, USFDA, inspected the plant.
The inspection happened from September 21 to 28, 2026.
Inspectors found one item to be addressed.
They did not report any data integrity problems.
Zydus said it would work closely with USFDA.
The company plans to resolve the observation quickly.
The company announced this on September 29, 2026.
USFDA completed a current Good Manufacturing Practice inspection at Zydus Lifesciences’ SEZ II facility in Ahmedabad.
The inspection took place from September 21 to 28, 2026.
The inspection concluded with one observation.
USFDA reported no data integrity-related observations, according to Zydus Lifesciences.
Zydus said it will work with USFDA to address the observation expeditiously.
- Who
- Zydus Lifesciences and the US Food and Drug Administration (USFDA).
- What
- USFDA completed a manufacturing-practice inspection with one observation and no data integrity-related observations.
- Where
- Zydus Lifesciences’ SEZ II manufacturing facility in Ahmedabad.
- When
- The inspection ran from September 21 to 28, 2026; Zydus announced the outcome on September 29, 2026.
- Why
- USFDA conducted a current Good Manufacturing Practice inspection; the articles do not state a further reason.
Key facts
- Company
- Zydus Lifesciences Ltd
- Regulator
- US Food and Drug Administration (USFDA)
- Facility
- SEZ II manufacturing facility
- Location
- Ahmedabad
- Inspection type
- Current Good Manufacturing Practice inspection
- Inspection dates
- September 21-28, 2026
- Outcome
- One observation; no data integrity-related observations
Sources
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