FDA 483 - Intas Pharmaceuticals Limited - December 14, 2018

Intas Pharmaceuticals Limited in Ahmedabad, India, was inspected by the FDA from December 10-14, 2018. The inspection revealed a significant issue regarding the failure to follow procedures designed to prevent microbiological contamination during the manufacturing of sterile drug products. Specifically, an operator was not monitored in the aseptic filling room as required by the firm's own SOPs, and logbooks lacked documentation of critical activities or personnel monitoring.