Glenmark’s Indore Plant Hit With 483, Confirms 3 Observations

Another Indian drugmaker has been hit with a form 483 by the FDA, which cited three observations at Glenmark Pharmaceuticals’ Pithampur, Indore plant.

The facility was inspected in February, and the firm said that all of the concerns were addressed within 30 days. Glenmark said it has since received approvals for two products from the targeted plant.

The nature of the observations was not discussed in the statement, and the 483 has not been released.