Alkem Laboratories informed that the US FDA has issued an Establishment Inspection Report (EIR) for the company’s manufacturing facility located at Indore which was inspected from July 1-7, 2022.
In response to Form 483 issued by the US FDA containing one observation, the company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The inspection has now been closed by the US FDA.