Halol in the Hot Seat: Sun Pharma Faces Eight FDA Observations After Inspection

Image Source: Moneycontrol

Sun Pharmaceutical Industries’ Halol manufacturing facility in Gujarat is once again under the spotlight after the US Food and Drug Administration (US FDA) completed a routine inspection and issued eight observations. The inspection, which took place from June 2 to June 13, 2025, focused on the plant’s compliance with Good Manufacturing Practices (GMP).

Key Highlights:

The US FDA concluded its inspection of the Halol unit by issuing a Form 483 with eight observations. These typically point to procedural or documentation lapses that require corrective action from the company.
Sun Pharma confirmed the development in a regulatory filing, stating it will respond to the observations and take all necessary steps to address the regulator’s concerns.
The Halol plant has a history of regulatory scrutiny. It was last inspected in May 2022 and has been under an import alert since then, following a previous warning letter. This status restricts the facility from exporting products to the US market until compliance issues are resolved.
The Halol facility is one of Sun Pharma’s largest, making the outcome of these inspections significant for the company’s US business. Previous inspections have flagged issues related to manufacturing quality, equipment maintenance, and staff training.

The latest inspection is part of ongoing efforts by the US FDA to ensure that overseas manufacturing sites meet strict quality standards for drugs supplied to the American market.

Sun Pharma’s next steps will be closely watched by investors and regulators as the company works to resolve the FDA’s concerns and restore full operations at the Halol site.

Sources: Moneycontrol, Business Upturn, CNBC-TV18