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Results For "FDA-inspection"

111 News Found

Biocon Biologics receives 5 procedural observations after US FDA inspection at Bengaluru facility
Biopharma | May 06, 2026

Biocon Biologics receives 5 procedural observations after US FDA inspection at Bengaluru facility

The US FDA completed a pre-license inspection of Biocon Biologics’ biosimilars manufacturing site at Biocon Park between April 20 and April 29, 2026


Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility
Drug Approval | May 04, 2026

Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility

The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026


Solara announces closure of US FDA inspection at Puducherry facility
Drug Approval | April 30, 2026

Solara announces closure of US FDA inspection at Puducherry facility

The Puducherry facility, dedicated to Ibuprofen and its derivatives, is equipped with advanced infrastructure to serve both domestic and international markets


Wanbury's Patalganga site clears Korea FDA inspection with zero observations
Drug Approval | April 30, 2026

Wanbury's Patalganga site clears Korea FDA inspection with zero observations

Patalganga plant received zero observation from USFDA earlier


Cipla receives two observations following USFDA inspection at Goa facility
Drug Approval | April 18, 2026

Cipla receives two observations following USFDA inspection at Goa facility

The company stated that it will work closely with the regulator to address the observations within the stipulated timeframe


Granules India’s US packaging facility clears FDA inspection with zero observations
Packaging | March 06, 2026

Granules India’s US packaging facility clears FDA inspection with zero observations

The inspection concluded with zero observations, confirming the facility's compliance with current Good Manufacturing Practices


Granules’ packaging facility in US completes FDA inspection with zero observations
News | December 05, 2025

Granules’ packaging facility in US completes FDA inspection with zero observations

Granules Consumer Health serves as Granules’ front-end division for OTC products in the US


Marksans Pharma's Goa unit clears FDA inspection
News | November 10, 2025

Marksans Pharma's Goa unit clears FDA inspection

The said inspection concluded with Zero Form 483 observation


Zydus’ SEZ II, Ahmedabad plant clears USFDA inspection with nil observations
Drug Approval | August 16, 2025

Zydus’ SEZ II, Ahmedabad plant clears USFDA inspection with nil observations

The inspection concluded with NIL observations