Cenexi's Fontenay manufacturing facility receives 10 observations in ANSM inspection
Cenexi is committed to working closely with the ANSM to address the observations
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
The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time
There was no observation related to data integrity reported
The company will closely work with the USFDA to address and respond to the observations in an expeditious manner
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