Unichem gets 5 observations from USFDA for Goa formulation facility

Unichem gets 5 observations from USFDA for Goa formulation facility

By: IPP Bureau

Last updated : July 17, 2024 11:12 am



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


The United States Food and Drug Administration (USFDA) conducted an inspection at the Unichem Laboratory's Goa formulation facility from 8th July 2024 to 15th July 2024.

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

The Company will provide the necessary response with in stipulated 15 working days. The observations do not impact business continuity and the Company's supplies to the US market.

Unichem Laboratory USFDA

First Published : July 17, 2024 12:00 am