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Results For "FDA-inspection"

111 News Found

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.


Dishman Carbogen Amcis updates on USFDA inspection at its Bavla facility
Drug Approval | March 09, 2024

Dishman Carbogen Amcis updates on USFDA inspection at its Bavla facility

The inspection was concluded with few procedural observations


USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva
News | December 02, 2023

USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva

The company has received Form 483 with three observations


NATCO Pharma announces successful completion of USFDA inspection
Drug Approval | November 02, 2023

NATCO Pharma announces successful completion of USFDA inspection

NATCO's Pharmacovigilance Department was inspected from October 30, 2023 to November 1, 2023


Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations
Drug Approval | August 16, 2023

Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.


USFDA inspection: Zydus Lifesciences and Gland Pharma
Drug Approval | January 28, 2023

USFDA inspection: Zydus Lifesciences and Gland Pharma

The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam


USFDA inspection at Indoco Remedies's Solid Oral Formulation Facility at Goa
Drug Approval | January 24, 2023

USFDA inspection at Indoco Remedies's Solid Oral Formulation Facility at Goa

USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.