Glenmark Pharmaceuticals gets OAI communication from US FDA for Goa plant

Glenmark Pharmaceuticals Limited said that the US Food and Drug Administration (FDA) has indicated that the inspection of the company’s Goa facility has been classified as “Official Action Indicated” (OAI).

The FDA inspection was carried out from 12 May to 20 May 2022 following which the regulator issued Form-483 with five observations.

Under the OAI classification, the FDA could deny granting approval of any pending product applications or supplements filed from the Goa facility till the resolving of the outstanding observations by Glenmark Pharmaceuticals.

The Indian pharma company stated: “Glenmark 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.”