FDA 483 - Intas Pharmaceuticals Limited - May 28, 2019

An FDA inspection of Intas Pharmaceuticals Limited in Ahmedabad, India, revealed multiple deficiencies across its manufacturing and quality control operations. The firm failed to adequately handle complaints, follow quality control procedures for out-of-trend results and batch record reconciliation, and establish proper in-process controls and hold time studies. Additionally, master production records lacked specific operating parameters, investigations into discrepancies were insufficient, and equipment cleaning procedures were incomplete.