In an exchange filing on Saturday, the company stated that the inspection concluded with the issuance of a Form 483 containing eight observations.
The development follows a CNBC-TV18 newsbreak on June 3,
citing sources who indicated that a surprise FDA inspection was likely underway at the Halol unit. At the time, three US FDA inspectors were said to be on site.
The Halol plant, one of Sun Pharma’s largest manufacturing sites, was last inspected in May 2022. It remains under an import alert after receiving a warning letter from the US FDA.
In response to earlier queries from CNBC-TV18, Sun Pharma had declined to comment on the timing of regulatory inspections, citing internal policy.
Shares of Sun Pharmaceutical Industries closed at ₹1,688.70, up 0.10%, on the BSE on Friday.
