Jubilant Pharmova Limited announced today that its subsidiary, Jubilant HollisterStier General Partnership (JHSGP), has received a communication from the US Food and Drug Administration (USFDA) regarding its Montreal, Canada contract manufacturing facility (CMO). The USFDA classified the facility’s inspection status as “Official Action Indicated” (OAI) following an audit conducted in June 2024.
The OAI classification signals that the regulatory authority has observed significant issues that require corrective actions. Jubilant Pharmova stated that JHSGP has been closely engaging with the USFDA since the audit and is working on remediation measures to address the concerns raised by the agency.
Jubilant Pharmova initially reported the USFDA audit on June 18, 2024, and has since committed to resolving the issues at its Montreal facility.
