FDA 483 - Recipharm Pharmaservices Private Limited - February 01, 2019

Recipharm Pharmaservices Private Limited in Bangalore, India, received a Form 483 with three observations during an inspection from January 28 to February 1, 2019. The observations primarily concern inadequate equipment qualification and control, insufficient process control procedures including data integrity issues, and failures in following gowning and sanitation procedures to prevent contamination in drug product manufacturing areas. These issues indicate significant deficiencies in the firm's quality systems and manufacturing controls.