FDA 483 - SCHOTT Pharma AG & Co. KGaA - August 14, 2019

SCHOTT AG, a medical device manufacturer in Mainz, Germany, received a Form FDA 483 with five observations following an inspection. The firm was cited for deficiencies including an unvalidated fiber gluing process, inadequate complaint file maintenance lacking MDR reporting evaluations, and insufficient documentation of corrective and preventive actions. Additionally, incomplete device history records and undocumented measuring equipment for incoming acceptance activities were noted, indicating a need for improved quality system compliance.