Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 2

Results For "FDA-inspection"

111 News Found

SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services
Drug Approval | June 27, 2025

SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services

The inspection concluded with zero Form 483 observations


USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
Drug Approval | June 17, 2025

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received one observation in the Form-483


USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
Drug Approval | June 13, 2025

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received 1 (One) observation in the Form-483


Innoxel Lifesciences completes USFDA inspection
Drug Approval | May 06, 2025

Innoxel Lifesciences completes USFDA inspection

This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence


USFDA inspection at Concord Biotech’s API facility at Dholka
Drug Approval | May 03, 2025

USFDA inspection at Concord Biotech’s API facility at Dholka

These observations are procedural in nature and none of them are related to data integrity


Neuland Laboratories completes USFDA inspection at Unit 2
Drug Approval | May 03, 2025

Neuland Laboratories completes USFDA inspection at Unit 2

The FDA issued Form 483 with one observation related to building and facility management


Closure of USFDA inspection at Zydus' API Unit at Dabhasa, Gujarat
Drug Approval | April 29, 2025

Closure of USFDA inspection at Zydus' API Unit at Dabhasa, Gujarat

The inspection concluded with 6 observations and none of them were related to Data Integrity


Shilpa’s Unit-2 passes second consecutive FDA inspection with no 483s
Drug Approval | April 09, 2025

Shilpa’s Unit-2 passes second consecutive FDA inspection with no 483s

Raichur site is the group’s largest API facility and part of a wider network of seven sites


SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility
Drug Approval | March 22, 2025

SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility

The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483