Sun Pharma’s Halol plant production facility in Gujarat has come under renewed scrutiny from the US Food and Drug Administration (US FDA). FDA issued 8 observations after current inspection.
According to a regulatory filing by agecy, 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 issued with 8 observations, indicating potential procedural or documentation lapses that need corrective action.
8 Observations received by Sun Pharma’s Halol plant
The Halol unit, certainly one of Sun Pharma’s largest manufacturing plants, has confronted regulatory action in the beyond. It was closing inspected in May 2022 and stays under an import alert after receiving a caution letter from US FDA, efficaciously restricting the plant from shipping products to the US market. Sun Pharma has said it’s going to reply to the observations and take all important steps to handle problems raised by regulator.
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