FDA 483 - Intas Pharmaceuticals Limited - February 28, 2020

An FDA inspection of Intas Pharmaceuticals Limited in Ahmedabad, India, revealed significant deficiencies in their quality control unit. The firm failed to ensure process validation for packaging was completed and approved before distributing drug batches to the US market. Additionally, the Quality Assurance unit did not conduct required manufacturing investigations following confirmed out-of-specification results for impurities in stability testing.