Alkem says US FDA has accepted plan to fix Ankaleshwar API plant
The Indian drug manufacturer announced it had received an Establishment Inspection Report (EIR) last Wednesday, explaining the US regulator has closed its investigation after reviewing its corrective and preventive action (CAPA) plan.
The US Food and Drug Administration (FDA) identified problems at the Gujarat plant during an inspection in December.
Alkem owns and operates 14 manufacturing facilities in India and two in the US. Its API plants are in Ankleshwar and Mandwa.
The EIR comes weeks after the US FDA issued Alkem with a Form 483 after an inspection at its facility in Himachal Pradesh.
The facility – in Baddi - was visited by an inspection team between March 2 and 10 resulting in a report containing three observations.
Alkem declined to share details of its remediation plan when contacted by in-Pharmatechnologist.com.