The US Food and Drug Administration had inspected company's facility at St. Louis in USA during August 16-22, 2019.
Shares of Alkem Laboratories gained a percent intraday on September 12 after receiving Establishment Inspection Report for its US manufacturing facility.
The US Food and Drug Administration had inspected company's facility at St Louis in USA from August 16-22, 2019. On August 23, company said it had received a Form 483 with four observations.
On September 11, Alkem informed exchanges that USFDA has issued an Establishment Inspection Report (EIR) for its manufacturing facility located at St Louis, Fenton Logistics Park, USA.
As a result, the inspection has now been closed by the USFDA, it said.