FDA 483 - Nightware - July 01, 2024

Nightware, a medical device manufacturer in Hopkins, MN, was inspected by the FDA from June 27 to July 1, 2024. The inspection revealed two significant issues: inadequate validation of device software, including documentation discrepancies and unvalidated mobile device management, and deficiencies in document control procedures, specifically regarding the maintenance of quality records and control of supplier monitoring forms. These observations indicate a need for improved quality system practices.