Gland Pharma concludes US FDA inspection with three observations
Gland Pharma announced the conclusion of a pre-approval inspection (PAI) by the United States Food and Drug Administration (US FDA) at its JNPC facility in Visakhapatnam. The inspection, which took place between February 19, 2025, and February 25, 2025, resulted in three Form 483 observations. The company stated that these observations are procedural in nature and that corrective and preventive actions will be submitted to the US FDA within the stipulated timeframe. Gland Pharma clarified that the observations are not repeated and are unrelated to data integrity. The company is committed to addressing the observations and providing updates as necessary. The company has assured that the incident has no major impact on the financial or operational activities of the company.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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