By: IPP Bureau
Last updated : March 19, 2023 8:14 am
The observations are procedural in nature
Bliss GVS Pharma Limited has announced that the United States Food and Drug Administration (US FDA) conducted a Pre-Approval Inspection (PAI) and Good Manufacturing Practice (GMP) inspection at the company's manufacturing unit at Dewan Udyog Nagar, Aliyali Village, Palghar, 401404, Maharashtra.
After the inspection, the US FDA issued a Form 483 with 3 minor observations. The observations are procedural in nature. None of the observations relate to data integrity. The Company shall prepare detailed response to the observations, which will be submitted to theUS FDA within the stipulated timelines.
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations.