Unichem receives Form 483 from USFDA with 3 observations for Roha API facility

Unichem receives Form 483 from USFDA with 3 observations for Roha API facility

By: IPP Bureau

Last updated : June 23, 2025 10:00 am



The company will provide the necessary response to USFDA within stipulated 15 days


The United States Food and Drug Administration (USFDA) conducted an inspection at Unichem Laboratories Ltd's Roha API facility from 16th June 2025 to 20th June 2025.

The inspection closed with three observations which were more of procedural changes with none of these related to data integrity.

The company will provide the necessary response to USFDA within stipulated 15 days.

Unichem Laboratories USFDA

First Published : June 23, 2025 12:00 am