Sun Pharmaceutical Industries Limited, one of India’s leading pharmaceutical companies, has announced the conclusion of a recent inspection by the United States Food and Drug Administration (US FDA) at its Halol manufacturing facility located in Gujarat, India.
The inspection was conducted from June 2 to June 13, 2025, as part of the regulatory authority’s routine evaluation of current Good Manufacturing Practices (GMP) compliance. At the end of the inspection, the US FDA issued a Form 483 to the company, outlining eight observations.
In a regulatory filing, Sun Pharma stated: “We hereby inform that the US FDA conducted a GMP inspection of our Halol facility from 02 June to 13 June 2025. At the conclusion of the inspection, the US FDA issued a Form-483 with 8 observations.”
A Form 483 is issued by the US FDA when its investigators observe any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related regulations. These observations are based on conditions found during routine inspections and are intended to prompt the company to take corrective actions.
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