The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.
The company is addressing these observations comprehensively
Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume
The company will provide the necessary response to USFDA within stipulated 15 days
The observations issued are neither repeated observations nor related to data integrity
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 company will address these observations within the stipulated timeline
There was no observation related to data integrity reported
The company is confident of addressing the concern raised by the USFDA
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