The USFDA has conducted a product-specific Pre-Approval Inspection (PAI) at Chhatrapati Sambhajinagar (Aurangabad) manufacturing facility from September 1 to September 5, 2025. The inspection closed with two observations. “We will address the observations and respond to the US FDA within the stipulated timeframe. We are committed to compliance with CGMP quality standards across all our facilities,” it said in a statement to the exchange.
said the USFDA conducted an inspection at the group’s injectable manufacturing plant at Jarod, near Vadodara, Gujarat. The inspection, conducted from August 25-September 5, 2025, concluded with four observations. There were no data integrity related observations. The company will work with the USFDA to address the observations expeditiously.
has informed thee exchanges that the US FDA has completed an inspection of its Unit-XII facility in Bachupally, Telangana, issuing a Form 483 with eight procedural observations. The company noted these are non-impactful and will submit a response within timelines.