The Alathur facility specializes in the production of Cephalosporin antibiotics
The inspection was carried out from January 28 to February 1, 2025
Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
The recent inspection covered both cGMP and PAI processes
The inspection was concluded with zero observations
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