Zydus Lifesciences Ahmedabad Plant Gets 1 USFDA Observation
Ahmedabad: The United States Food and Drug Administration (USFDA) has concluded a current Good Manufacturing Practices (cGMP) inspection at Zydus Lifesciences' manufacturing plant at SEZ II, Ahmedabad, with the inspection resulting in one observation and no observations related to data integrity.
The inspection was conducted at the company’s manufacturing facility from September 21 to September 28, 2026.
The company stated that the USFDA inspection of its SEZ II manufacturing plant in Ahmedabad was conducted as a cGMP inspection during the eight-day period. Following completion of the inspection, the facility received one observation from the US regulatory authority.
Importantly, Zydus Lifesciences stated that no data integrity-related observations were reported during the inspection. The company said it will work closely with the USFDA to address the observation expeditiously.
The inspection outcome relates specifically to the company’s manufacturing facility at SEZ II, Ahmedabad, and the disclosure does not provide further details about the nature or specific subject matter of the single observation.
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