FDA 483 - Hikal Limited - August 01, 2019

An inspection of Hikal Limited, an active pharmaceutical manufacturer in Anekal Taluk, Bangalore, revealed significant deficiencies in their laboratory procedures and record-keeping practices. Specifically, records for microbial testing were not completed at the time of performance, and documentation for bioburden analysis was found to be inadequate. These issues impact drug substances intended for both European and US markets.