US FDA Flags 8 Observations at Sun Pharma’s Halol Facility After GMP Inspection

15 Jun 2025 , 11:50 PM

Sun Pharma has confirmed that its Halol plant in Gujarat was inspected by the U.S. FDA earlier this month. The visit lasted from June 2 to June 13 and focused on checking for compliance with Good Manufacturing Practices.

In a filing made public on Saturday, the company said the inspection concluded with the U.S. regulator issuing a Form 483, listing eight separate observations. No specifics were shared regarding the nature or severity of the issues raised.

The news comes days after speculation surfaced in the media. On June 3, U.S. inspectors had arrived at the Halol facility for what appeared to be an unannounced audit. At that point, three officials from the FDA were believed to be on site.

This isn’t the first time the Halol unit has drawn attention from regulators. The same facility was reviewed back in May 2022 and has remained under an import alert ever since. That action followed a warning letter issued by the FDA, and the alert remains active to date.

When sources approached for a comment last week about the ongoing inspection, Sun Pharma declined to share details, pointing to internal policies that prevent it from discussing regulatory matters in real-time.

Sun Pharmaceutical Industries is currently the largest drugmaker in India. On the global stage, it ranks among the top five producers of specialty generics. Its operations span a wide mix of products from branded medicines and over-the-counter drugs to APIs and high-value generics.

The company has built a manufacturing presence that stretches across continents. With more than 40 production sites worldwide and a commercial footprint in over 100 countries, the company remains heavily exposed to U.S. regulatory oversight especially as it continues to rely on the American market as a key driver of growth.

For feedback and suggestions, write to us at [e-mail]