The US FDA has issued an Establishment Inspection Report (EIR) for Alkem Laboratories' manufacturing facility located at Baddi, India which was inspected from 13th May, 2019 to 11 May 2019. Alkem Labs had earlier received a Form 483 issued by the US FDA containing four observations, and the company had submitted a corrective and preventive action (CAP A) plan to the regulator within the stipulated timelines.
The inspection has now been closed by the US FDA, with the EIR. To see all FDA search results in filings, try Discover.