Panacea Biotec Ltd. on Thursday said the U.S. 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 U.S. Food and Drug Administration (USFDA) had inspected the Baddi unit of its subsidiary, Panacea Biotec Pharma Ltd. (PBPL) from May 30 to June 8. Subsequently, the USFDA issued Form 483 with eight observations which are related to improvements in existing procedures and are addressable, Panacea Biotec said in a regulatory filing.
According to the U.S. Food and Drug Administration (USFDA), 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 USFDA indicating the inspection classification as Official Action Indicated (OAI)".
The OAI classification implies that the U.S. 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.
"PBPL is working closely with USFDA to close these observations and the closure of the warning letter issued by the USFDA earlier on September 24, 2020," the filing said.
The warning letter was issued for non-compliance with the current good manufacturing practice outlined by the USFDA.
It further said PBPL continues to manufacture and distribute existing products for the U.S. market, thereby not likely to have any material adverse impact on current business from the facility.