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Results For "FDA-inspection"

111 News Found

Orchid Pharma's Alathur API facility successfully completes USFDA inspection
Drug Approval | February 20, 2025

Orchid Pharma's Alathur API facility successfully completes USFDA inspection

The Alathur facility specializes in the production of Cephalosporin antibiotics


Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations
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


Granules India update on USFDA inspection at Gagillapur facility
News | December 05, 2024

Granules India update on USFDA inspection at Gagillapur facility

Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA


USFDA inspection of Shilpa Medicare Unit VI at Bengaluru
Drug Approval | November 02, 2024

USFDA inspection of Shilpa Medicare Unit VI at Bengaluru

The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature


USFDA inspection update on Jubilant HollisterStier’s Montreal facility
Drug Approval | September 30, 2024

USFDA inspection update on Jubilant HollisterStier’s Montreal facility

HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures


Granules India’s Gagillapur facility completes USFDA inspection with six observations
Drug Approval | September 09, 2024

Granules India’s Gagillapur facility completes USFDA inspection with six observations

The recent inspection covered both cGMP and PAI processes


Caplin Point announces completion of unannounced USFDA inspection
Drug Approval | August 11, 2024

Caplin Point announces completion of unannounced USFDA inspection

The inspection was concluded with zero observations