FDA 483 - Crest Electronics Inc - December 28, 2022

Crest Electronics Inc, a medical device manufacturer in Dassel, MN, was cited for multiple quality system deficiencies during an FDA inspection. The firm's procedures for design change, nonconforming product disposition, incoming product acceptance, sampling methods, and process controls were found to be inadequately established. These issues indicate a systemic lack of documented and followed procedures essential for ensuring product quality and regulatory compliance.