Alkem issued with Form 483 by US FDA
The Form 483 – detailed in a filing on the Bombay Stock Exchange (BSE) today – lists three problems US Food and Drug Administration (FDA) investigators identified at the facility during an inspection this month.
Alkem said it is working on a response. The firm did not give details of the issues identified by the the US team.
The Form 483 comes a little over two months after Alkem's facility in finished dosage form plant in Daman passed an FDA inspection with no observations.
Alkem owns and operates 14 manufacturing facilities in India and two in the US. Its API plants are in Ankleshwar and Mandwa.