FDA 483 - Scholly Fiberoptic GmbH - September 28, 2023

Scholly Fiberoptic GmbH, a medical device manufacturer in Denzlingen, Germany, was cited for significant deficiencies in its quality system during an FDA inspection. The firm's corrective and preventive action procedures were found ineffective, leading to recurring product issues. Additionally, complaint handling procedures failed to adequately evaluate complaints for Medical Device Reporting, and device history records were incomplete regarding labeling information.