Zydus Lifesciences announced the closure of the Pre-Approval Inspection (PAI) conducted by the US Food and Drug Administration (USFDA) at its Unit 9 Injectable Medical Devices facility in Ahmedabad. The inspection took place between February 16th and February 19th, 2026. The company confirmed that the inspection successfully concluded with NIL observations, a highly favorable outcome for regulatory compliance and future product approvals.
USFDA Inspection Concludes Favorable for Zydus
Zydus Lifesciences Limited issued a press release on February 19, 2026, confirming the successful conclusion of a significant regulatory inspection. The US, Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection (PAI) focusing on Injectable Medical Devices at the company’s Unit 9 facility.
Facility and Inspection Dates
The inspection was held at the Unit 9 facility, located at Zydus Biotech Park, Changodar, Ahmedabad. The audit period spanned four days, starting on February 16th, 2026, and concluding on February 19th, 2026.
Key Outcome: Zero Observations
The most crucial highlight of the announcement is that the inspection closed with NIL observations. This result signifies that the facility is currently compliant with stringent USFDA requirements for injectable medical devices, positively impacting potential future product approvals from the agency.
Compliance Disclosure
The company has communicated this news to the stock exchanges as a voluntary disclosure, ensuring investors and members are fully appraised of the successful regulatory standing of their key manufacturing assets.
Source: BSE
