Zydus Lifesciences said the US Food and Drug Administration has concluded an inspection of its SEZ II manufacturing facility in Ahmedabad with one observation and no data integrity issues.

The current Good Manufacturing Practice inspection was held from 21 to 28 September 2026, the company said in a regulatory filing. The company said it will work closely with the US regulator to address the observation quickly.

A clean record on data integrity is a major positive for drugmakers. Serious findings in this area can lead to warning letters or import bans, which can hit exports hard.

In a separate development, the company’s New Jersey office cleared a four-day USFDA inspection of its pharmacovigilance and post-marketing surveillance systems from 22 to 25 September with zero observations.

The company also reported its first-quarter results for FY27. Operational revenue grew 22 per cent to Rs 8,017 crore, while net profit fell 35.9 per cent to Rs 939.8 crore.