FDA 483 - Sever Pharma Solutions - December 15, 2017

QPharma AB, a manufacturer in Malmo, Sweden, received a Form FDA 483 with four observations. The firm failed to thoroughly investigate manufacturing discrepancies and lacked adequate control procedures to detect metal particles in drug products. Additionally, electronic records did not meet retention requirements, and the firm could not demonstrate that equipment surfaces contacting in-process materials were pharmaceutical grade.