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Results For "Form-483"

117 News Found

Briefs: Indoco Remedies and Alembic Pharmaceuticals
Drug Approval | July 29, 2024

Briefs: Indoco Remedies and Alembic Pharmaceuticals

Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe


USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau
Drug Approval | July 24, 2024

USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau

The inspections concluded with no Form 483 observations or significant critical findings


Cipla gets 6 observations from USFDA for Goa facility
Drug Approval | June 24, 2024

Cipla gets 6 observations from USFDA for Goa facility

The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time


Briefs: Dr. Reddy's Laboratories and Ami Organics
News | June 08, 2024

Briefs: Dr. Reddy's Laboratories and Ami Organics

Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility


Cipla receives 1 observation from USFDA for Kurkumbh facility
Drug Approval | May 10, 2024

Cipla receives 1 observation from USFDA for Kurkumbh facility

The company is committed to address this observation comprehensively within stipulated time


Cipla Patalganga facility gets 6 USFDA observations
Drug Approval | April 07, 2024

Cipla Patalganga facility gets 6 USFDA observations

The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.


Briefs: Alkem Laboratories and Zydus Lifesciences
Drug Approval | March 28, 2024

Briefs: Alkem Laboratories and Zydus Lifesciences

USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant


Briefs: Concord Biotech and Neuland Laboratories
Drug Approval | March 23, 2024

Briefs: Concord Biotech and Neuland Laboratories

The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483


USFDA conducts inspection at Alembic Pharmaceuticals' Panelav oncology formulation facility
Drug Approval | March 09, 2024

USFDA conducts inspection at Alembic Pharmaceuticals' Panelav oncology formulation facility

The company will provide comprehensive response to USFDA for the observations