US FDA completes inspection of Alkem’s manufacturing facility in Indore
In response to Form 483 issued by the US FDA containing one observation, the company had submitted a detailed CAPA plan to the regulator
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.
- Advertisement -