US FDA issues observations following inspections of Indian drugmakers

The US Food and Drug Administration (FDA) has concluded inspections at two major Indian pharmaceutical manufacturing facilities, issuing Form 483 observations at both sites.

At Zydus Lifesciences’ Moraiya plant in Gujarat, inspectors identified five observations following a visit from October 5 to 13. Issues cited included discrepancies in quality lab records where test plates showing growth were logged as ‘no growth,’ insufficient investigation into unexplained results such as metal shavings complaints, and failures to identify root causes for off-trend results in products sent to the US. Additionally, the FDA noted procedural gaps regarding the handling of suspect products and insufficient testing of incoming materials despite previous failures.

Separately, the FDA concluded an inspection of Lupin’s facility in Goa from October 19 to 23, 2026, resulting in a single observation. Lupin has stated it intends to address the observation and respond to the regulator within the required timeframe.