FDA 483 - Greiner Bio-One GmbH - October 25, 2018

Greiner Bio-One GmbH, a medical device manufacturer in Kremsmuenster, Austria, received a Form 483 with seven observations. The inspection revealed significant deficiencies in design control, process validation, corrective and preventive actions, medical device reporting, complaint handling, change control documentation, and supplier control. These issues indicate a broad lack of established and implemented quality system procedures.