Sun Pharma's Halol plant gets 8 observations from US FDA after latest inspection

Sun Pharma has said it will respond to the observations and take all necessary steps to address the concerns raised by the regulator.

Sun Pharmaceutical Industries Ltd’s Halol manufacturing facility in Gujarat has come under renewed scrutiny from the United States Food and Drug Administration (US FDA), which issued eight observations following a recent inspection.

According to a regulatory filing by the company, the US FDA conducted a Good Manufacturing Practices (GMP) inspection at the Halol site from June 2 to June 13, 2025. At the end of the inspection, a Form 483 was issued with eight observations, indicating potential procedural or documentation lapses that need corrective action.

The Halol unit, one of Sun Pharma’s largest manufacturing plants, has faced regulatory action in the past. It was last inspected in May 2022 and remains under an import alert after receiving a warning letter from the US FDA, effectively restricting the plant from shipping products to the US market.

Sun Pharma has said it will respond to the observations and take all necessary steps to address the concerns raised by the regulator.