Sun Pharmaceutical Industries Ltd’s Halol plant in Gujarat has received eight observations from the US Food and Drug Administration (US FDA) after a recent inspection. The inspection was conducted between June 2 and June 13, 2025, as per the company’s official filing.
The US FDA issued a Form 483 which means the inspection team saw some procedural or documentation issues related to manufacturing at the site. These need to be corrected by the company.
This Halol facility is one of Sun Pharma’s main manufacturing sites and has faced regulatory issues earlier. The same site was inspected in May 2022 and is still under import alert following a warning letter. This means it cannot export to US market.
Sun Pharma will address all the observations and will submit a detailed response to US FDA soon. The company will take all the corrective actions as required by the global regulator.
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Source: Moneycontrol
News Desk
