The United States Food and Drug Administration (USFDA) has conducted an inspection of Panacea Biotec’s material wholly-owned subsidiary, Panacea Biotec Pharma (PBPL) at Baddi, Himachal Pradesh, India between May 30, 2022 and June 08, 2022.
At the end of inspection, PBPL was issued a 'FDA Form 483' with 8 observations which are related to improvements in existing procedures and are addressable. PBPL will respond to the US FDA within the stipulated time period and work closely with US FDA to close the said observations and the closure of Warning Letter issued by the US FDA earlier on September 24, 2020. The company is committed to patient safety and quality and take quality and compliance matters seriously and stand by its commitment to fully comply with the cGMP quality standards.
Panacea Biotec is a leading research based Biotechnology Company with established research, manufacturing and marketing capabilities.
