BLISS GVS PHARMA LTD. - 506197 - Intimation About Completion Of US FDA Inspection At Plot 11 Of The Company
This is to inform you 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 Plot No. 11, Survey No. 38/1, Dewan Udyog Nagar, Aliyali Village, Palghar, 401404, Maharashtra from Monday, March 13, 2023 to Friday, March 17, 2023. 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 the US 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.18-03-2023