Institute of Good Manufacturing Practices India®

Zero observation obtained by Hikal from US FDA for Panoli facility


Hikal Ltd has successfully completed USFDA audit at Panoli, Gujarat, with zero Form 483 observations.

The inspection was conducted between September 9 and 13, 2019.
As stated by the company during filing that the inspection assured the site to be in compliance with the principles and guidelines of Current Good Manufacturing Practices (cGMP).  

Establishment Inspection Report obtained has categorized the facility under No Action Indicated (NAI) for the compliance of cGMP.