FDA 483 - Maropack AG - February 11, 2022

An FDA inspection of Maropack AG, a sterile pharmaceutical manufacturer in Zell, Switzerland, revealed significant deficiencies in preventing microbiological contamination of sterile drug products. The firm failed to establish and follow procedures for aseptic interventions, conduct adequate deviation investigations for out-of-limit results, and ensure the efficacy of disinfectants. Additionally, the inspection found a lack of written investigations for monitoring excursions and issues with the quality control unit's change control procedures.