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Results For "inspection"

465 News Found

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


USFDA completes inspection at Biocon Biologics’ facilities in Bengaluru
News | July 29, 2024

USFDA completes inspection at Biocon Biologics’ facilities in Bengaluru

The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants


Shilpa Pharma Lifesciences’ Unit 2 Raichur has cleared the ANVISA-Brazil GMP inspection
News | July 10, 2024

Shilpa Pharma Lifesciences’ Unit 2 Raichur has cleared the ANVISA-Brazil GMP inspection

The Unit has been issued GMP Certification from ANVISA-Brazil


Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations
Drug Approval | April 14, 2024

Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations

This facility manufactures APIs & formulations of oncology and non-oncology products.


USFDA completes inspection of Lupin's Dabhasa facility with no observations
Drug Approval | April 13, 2024

USFDA completes inspection of Lupin's Dabhasa facility with no observations

The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations


Lupin receives Form 483 with 1 observation from USFDA after inspection at Aurangabad facility
Drug Approval | March 16, 2024

Lupin receives Form 483 with 1 observation from USFDA after inspection at Aurangabad facility

The company is confident of addressing the concern raised by the USFDA