Punjab: Panacea Biotech has recently announced that its material wholly-owned subsidiary, Panacea Biotec Pharma Limited (“PBPL”) has received eight observations from United States Food and Drug Administration (USFDA) at the end of the inspection.
“At the end of inspection, PBPL was issued a ‘FDA Form 483’ with eight (8) observations which are related to improvements in existing procedures and are addressable,” the company stated.
FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
“PBPL will respond to the USFDA within the stipulated time period and work closely with USFDA to close the said observations and the closure of Warning Letter issued by the US FDA earlier on September 24, 2020,” the company added in a BSE filing.
“We are committed to patient safety and quality and take quality and compliance matters seriously and stand by our commitment to fully comply with the cGMP quality standards,” Panacea further added.