Panacea Biotec Pharma Ltd's Baddi plant classified as OAI by USFDA

Panacea Biotec Pharma Limited ("PBPL"), material Wholly-owned Subsidiary of Panacea Biotec Limited has now received a communication from the USFDA indicating the inspection classification as "Official Action Indicated" (OAI). The OAI classification implies, that the USFDA 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.

PBPL is working closely with USFDA to close these observations and the closure of Warning Letter issued by the USFDA earlier on September 24, 2020.

The company is committed to patient safety & quality and take quality & compliance matters seriously and stand by its commitment to fully comply with the cGMP quality standards.

PBPL continues to manufacture and distribute existing products for the US market, thereby not likely to have any material adverse impact on current business from the facility.

The United States Food and Drug Administration ("US FDA") had inspected Panacea Biotec Pharma Limited's facility at Baddi, Himachal Pradesh, India from May 30 to June 08, 2022 and issuance of Form-483 by USFDA with eight (8) observations which are related to improvements in existing procedures and are addressable.

Source : Equity Bulls

Keywords

PanaceaBiotec PanaceaBiotecPharma USFDA Inspection OAI OfficialActionIndicated Baddi