US FDA issues Form 483 with three observations for Bliss GVS Pharma’s Palghar unit

Bliss GVS Pharma, on Saturday, said the United States Food and Drug Administration (US FDA) has issued form 483 with three minor observations at company’s manufacturing facility in Plaghar, Maharashtra.

In an exchange filing, the pharmaceutical company said, “After the inspection, the US FDA issued a Form 483 with three minor observations. The observations are procedural in nature.”

US FDA had 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 March 13 to March 17, 2023, the company said.

Furthermore, the company said that none of the observations relate to data integrity, and the company shall prepare detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines.

Founded in 1984, Mumbai-based Bliss GVS Pharma is a pharmaceutical company that develops, manufactures, and markets pharmaceutical formulations. Additionally, the company went public nearly three decades later in July 2010.

Bliss GVS Pharma’s stock settled at Rs 75.15 apiece, down 1.70 percent, when the market closed on Friday, March 17.