Strides Pharma Science Ltd shares will remain in focus after the US Food and Drug Administration (USFDA) issued three observations following an inspection of the company’s formulations facility in Alathur, Chennai. 

The USFDA conducted the routine current Good Manufacturing Practices (cGMP) inspection at the facility from September 2 to September 11, 2026. At the end of the inspection, the regulator issued a Form 483 containing three observations.

A Form 483 is issued when USFDA inspectors identify conditions that may need corrective action. However, the observations do not automatically mean that the facility faces regulatory action or that its operations have been halted.

Strides Pharma said it will submit its response to the USFDA within the stipulated timeframe. The company is expected to address the observations and provide the necessary corrective and preventive measures to the regulator.

The latest inspection outcome comes after the Alathur facility received two observations during its previous USFDA inspection in April 2024. That earlier inspection was eventually closed with a Voluntary Action Indicated classification and an Establishment Inspection Report in August 2024.

The development also follows another recent regulatory update for Strides Pharma. In May 2026, the USFDA inspected the company’s flagship Bengaluru facility and issued five observations. 

After reviewing the company’s corrective and preventive actions, the regulator classified the inspection as Voluntary Action Indicated and formally closed it through an Establishment Inspection Report in August.

At 12:05 pm, the shares of Strides Pharma were trading 0.96% higher at Rs 1,194.80 on NSE. 

Discover the next big investment! Tradz by EquityPandits’ IPO screener helps you identify promising initial public offerings. Download Tradz by EquityPandit and get ahead of the curve! Sign Up Now & Find Your Next IPO Gem!