The United States Food & Drug Administration (USFDA) today completed a GMP and Pre-Approval Inspection (PAI) at our R&D centre (Integrated Product Development Organisation or IPDO) in Bachupally, Hyderabad. The inspection was conducted from December 4, 2023 to December 8, 2023.
The company has been issued a Form 483 with three observations, which we will address within the stipulated timeline.
InvaGen Pharmaceuticals Issues Voluntary Nationwide Recall of Vigabatrin for Oral Solution, USP 500mg due to Leaking Sachets
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