Alkem gets EIR report from USFDA for Baddi facility

Drug firm Alkem Laboratories today said it has received an establishment inspection report (EIR) from the US health regulator on closure of inspection of its Baddi facility.
The US Food and Drug Administration (USFDA) has issued an EIR for the company's manufacturing facility located at Baddi, Himachal Pradesh, Alkem Laboratories said in a regulatory filing.
The USFDA had inspected the plant from September 11, 2017 to September 15, 2017.
The company said it had submitted a detailed corrective and preventive action (CAPA) plan to the USFDA within the stipulated time lines in response to the two Form 483 observations issued by the regulator.

"The inspection has now been closed by the USFDA," it added.
USFDA releases a copy of the EIR to the establishment that is subject of an FDA or FDA-contracted inspection when the agency determines the same to be closed.
Alkem shares today ended 5.74 per cent higher at Rs 2,347.70 apiece on the BSE.