FDA Classifies Glenmark Inspection as Official Action Indicated
Glenmark Pharmaceuticals’ facility in Baddi, India is under FDA Official Action Indicated (OAI) status following a June inspection of the manufacturing plant.
When an inspection is classified as OAI, the agency’s first step is usually a warning letter.
In a notice to the Indian stock exchange, Glenmark said it will engage with the FDA to resolve the deficiencies observed during the inspection.
The firm has also been placed on an import alert requiring products to be detained without physical examination at U.S. ports.