Glenmark Pharma Monroe, North Carolina (USA) based Facility has received a communication from the US FDA indicating the inspection classification as Official Action Indicated (OAI).
The OAI classification implies interalia that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved.
US FDA inspection at Glenmark’s Monroe, North Carolina (USA) facility from April 04 to May 19, 2022 and issuance of Form‐483 by US FDA with 17 observations
The Company had done a voluntary recall of all its products from this site in August 2021 and since then has not been commercializing any product from this site.
Glenmark said that it continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest. The Company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe
