Shares of Sun Pharmaceutical Industries Ltd were trading in the red and 1.68% lower on 3 July after the US Food and Drug Administration (USFDA) slapped its Dadra unit with a warning letter last month. The letter highlighted multiple repeat observations leading to strict regulatory action.

The warning letter highlighted repeated violations, including insufficient oversight and control over drug manufacturing and the failure to operate an effective quality system.

The warning letter added that the company has also failed to clean, maintain, and sanitize equipment to appropriate intervals and investigate unexplained discrepancies in a batch or its components.

The USFDA inspected the Pharma major’s Dadra unit between 4 December and 15 December 2023 and concluded the inspection with the facility as ‘Official Action Indicated’ (OAI).

A facility is classified as OAI when serious compliance issues are found. Failure to resolve the problems within the stipulated time could lead to the unit facing export, regulatory, or administrative curbs.

Failing to rectify observations issued by the US regulator resulted in the company receiving a warning letter from the USFDA.

At 10:26 am, the shares of Sun Pharmaceutical were trading 0.31% higher at Rs 1,538.70 on NSE.