Bliss GVS Pharma 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 Plot No. 11, Survey No. 38/1, Dewan Udyog Nagar, Aliyali Village, Palghar, 401404, Maharashtra from Monday, March 13 to March 17, 2023.

After the inspection, the US FDA issued a Form 483 with 3 minor observations. The observations are procedural. None of the observations relates to data integrity. The company will prepare a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines.