The FDA issued a warning letter to Lupin Pharmaceuticals over repeated failures at its Mandideep site near Bhopal in central India, including inadequate out-of-specification investigations.
An inspection of the facility revealed three failures that were also observed at two other Lupin facilities, and the FDA advised the company to “immediately and comprehensively” assess its global manufacturing operations.
The facility’s investigations into OOS assay results were not up to par, the agency found. Since 2016, the facility launched a “substantial number” of OOS investigations for multiple drug products but frequently closed them without finding a root cause, the agency said. It also released batches based on passing retest results.