Panacea Biotec yesterday said the US health regulator has asked for further corrective actions at the manufacturing unit of its wholly-owned arm at Baddi in Himachal Pradesh otherwise approval of any pending product applications from the facility may be withheld.
The US Food and Drug Administration (FDA) had inspected the Baddi unit of its subsidiary, Panacea Biotec Pharma from 30th May to 8th June, 2022. Subsequently, the FDA issued Form 483 with eight observations which are related to improvements in the existing procedures and are addressable, Panacea Biotec said in a regulatory filing.
According to the FDA, Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The company said it has “now received a communication from the FDA indicating the inspection classification as Official Action Indicated (OAI).”
The OAI classification implies that the FDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved, it added.
Panacea Biotech is working closely with FDA to close these observations and the closure of the warning letter issued by the FDA earlier on 24th September 2020, the filing said.
The warning letter was issued for non-compliance with the current good manufacturing practice outlined by the FDA.
It further said Panacea Biotec continues to manufacture and distribute the existing products for the US market, thereby not likely to have any material adverse impact on current business from the facility.
Edits by EP News Bureau