Mumbai, April 21 -- The inspection of the General Injectables Block was carried out from 13 April to 17 April 2026 and concluded on 20 April 2026.

At the conclusion of the inspection, the USFDA issued five observations under a Voluntary Action Indicated (VAI) classification. The company said its subsidiary will respond within the prescribed timeline, while the final Establishment Inspection Report (EIR) is awaited.

The General Injectables Block is a key facility that supports the supply of sterile injectable formulations to regulated markets, including the United States and the European Union.

Commenting on the development, the company's management said, "A surprise USFDA inspection of a sterile injectables block, concluding with a few...