By: IPP Bureau
Last updated : March 05, 2025 1:03 pm
The company will provide the necessary response on these observations to USFDA within stipulated 15 days
The United States Food and Drug Administration (USFDA) conducted an inspection at Unichem Laboratories Ltd's Pithampur API facility from 24th February 2025 to 28th February 2025.
The inspection closed with four observations which were more of procedural changes with none of these related to data integrity.
The company will provide the necessary response on these observations to USFDA within stipulated 15 days.