Drug Approval | March 05, 2025
Unichem Laboratories receives 4 observations from USFDA for Pithampur API facility
The company will provide the necessary response on these observations to USFDA within stipulated 15 days
The company will provide the necessary response on these observations to USFDA within stipulated 15 days
The observations issued are neither repeated observations nor related to data integrity
Observations are largely around improvement of procedures and practices
The Alathur facility specializes in the production of Cephalosporin antibiotics
The inspection concluded with the issuance of a form 483 with five observations
The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
The inspection was concluded with two 483 observations
The inspection closed with five observations which were more of procedural changes with none of these related to data integrity
There was no observation related to data integrity reported
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