Regulatory28 Sep 2026 · 6:09 PM IST
ZYDUSLIFEZydus Lifesciences
USFDA records one observation at Zydus's Ahmedabad SEZ II plant
The US drug regulator inspected the company's manufacturing plant at SEZ II, Ahmedabad, from 21 to 28 September and recorded one observation.
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- Sector
- Pharma
What happened
- The US Food and Drug Administration (USFDA) carried out a current good manufacturing practice (cGMP) inspection of Zydus Lifesciences' manufacturing plant at SEZ II in Ahmedabad.
- The inspection ran from 21 to 28 September 2026 and ended with one observation, the company disclosed on Monday evening.
- During Monday's session, the company had said a separate USFDA inspection of its office in New Jersey, US, ended with no observations.
Why it matters
Good to know: An observation is a point the inspector raises at the end of an inspection, usually listed on a document called Form 483. The company replies with a plan to fix it. The USFDA later decides how to classify the inspection outcome.
Key facts
- Facility
- Manufacturing plant, SEZ II, Ahmedabad
- Inspection dates
- 21–28 September 2026
- Observations
- One
Read the source
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