Drug Approval | July 24, 2023
Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village
Aurobindo will respond to the US FDA within the stipulated timelines
Aurobindo will respond to the US FDA within the stipulated timelines
The company will submit its comprehensive response on these observations to the USFDA
This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites
The company will submit its comprehensive response on these observations to the US FDA within the stipulated time
The audit is a pre-approval inspection for three products filed from the facility
The observations are procedural in nature
The company will be submitting the responses to US FDA observations within stipulated timeline
The company had responded to the agency and carried out the required corrective actions.
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
There are no data integrity (DI) observations.
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