USFDA Flags Zydus Lifesciences' Gujarat Facility for Regulatory Issues
Zydus Lifesciences' injectables manufacturing facility in Jarod, near Vadodara, has been classified as 'Official Action Indicated' by the USFDA following an inspection. This implies regulatory concerns and potential withholding of pending product approvals. The company aims to resolve the issues swiftly.
![USFDA Flags Zydus Lifesciences' Gujarat Facility for Regulatory Issues](https://devdiscourse.blob.core.windows.net/aiimagegallery/18_07_2024_12_46_24_1870361.png)
- Country:
- India
Zydus Lifesciences Ltd faces regulatory hurdles as the USFDA classified its injectables manufacturing facility in Jarod, near Vadodara, Gujarat, as 'Official Action Indicated' (OAI) following an inspection from April 15 to April 23, 2024. This classification signals significant compliance issues.
The USFDA's OAI classification means pending product applications or supplements from this facility may be withheld until all compliance concerns are addressed. This presents a significant challenge for the company as it seeks to maintain its standing in the pharmaceutical market.
In a regulatory filing, Zydus Lifesciences stated its commitment to resolving these issues promptly in collaboration with the US regulatory agency. The company is focused on addressing the outstanding observations to regain operational approval.
(With inputs from agencies.)
ALSO READ
Delhi LG Orders Comprehensive Monthly Inspections to Curb Civic Infrastructure Collapse
Delhi LG Pushes for Regular Infrastructure Inspections Amid Monsoon Concerns
FAA Orders Inspections of Boeing 787 Dreamliners After Safety Incidents
Delhi Govt to Privatize Vehicle Inspection Centre in Jhuljhuli
FAA Mandates Boeing 787 Inspections Following Mid-Air Dive Incident