Drug Approval | February 03, 2025
Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations
The inspection was carried out from January 28 to February 1, 2025
The inspection was carried out from January 28 to February 1, 2025
Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations
The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
Cenexi is committed to working closely with the ANSM to address the observations
The observations are of procedural in nature and will be responded to within the stipulated time
The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices
The recent inspection covered both cGMP and PAI processes
The inspection closed with five observations which were more of procedural changes with none of these related to data integrity
The company will address these observations within the stipulated timeline
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The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time
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