Shares of Sun Pharmaceutical Industries Ltd, India’s largest drugmaker, saw its shares fall almost 2% on Monday, 16 June, after the US Food and Drug Administration (USFDA) issued eight observations for its Halol production facility in Gujarat.

Sun Pharma stated in a regulatory filing that the USFDA performed a Good Manufacturing Practices (GMP) examination at its Halol facility from 2 June to 13 June 2025. 

The inspection concluded with the issuance of a Form 483 with eight observations indicating potential procedural or documentation errors that required corrective action.

The Halol factory, one of the company’s main manufacturing sites, has previously received regulatory inspection and has been on import alert since May 2022, when a warning letter was issued prohibiting exports to the United States.

Sun Pharma claimed that it will address the observations and implement the necessary corrective steps.

The USFDA issued an import notice on the plant following the inspection in April-May 2022, and it was later classed as OAI (Official Action Indicated) in August 2022. During that examination, the USFDA issued ten Form 483 observations. The observations focused on manufacturing systems, facilities and equipment, quality control procedures, and lab control systems. The plant has been classed as OAI since March 2020.

Even during the December 2019 visit, the US FDA made eight Form 483 observations. The site has previously experienced a number of poor regulatory outcomes. In addition, it received a warning notice in 2015.

At 12:45 pm, the shares of Sun Pharma were trading 0.21% lower at Rs 1,686.10 on NSE. 

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