FDA 483 - Modulight, Inc. - April 21, 2022

Modulight, Inc. in Tampere, Finland, a manufacturer of class III medical devices, was cited by the FDA for multiple quality system deficiencies. The inspection revealed inadequate documentation for software validation and design verification, insufficient risk analysis, and poorly established procedures for incoming material acceptance and supplier assessment. These observations indicate significant issues in the firm's controls for their ML6710i Laser product.