Last Updated on October 9, 2024 by The Health Master
Bliss GVS Pharma said the United States Food and Drug Administration (USFDA) 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 USFDA issued a Form 483 with three minor observations. The observations are procedural in nature.”
USFDA had conducted a Pre-Approval Inspection (PAI) and Good Manufacturing Practice (GMP) inspection at the company’s manufacturing unit at Palghar, 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 USFDA 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.
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