FDA 483 - Starkey Laboratories Inc - November 13, 2018

An FDA inspection of Starkey Labs Inc in Eden Prairie, MN, conducted from November 7-13, 2018, identified a significant deficiency related to document control. The firm failed to adequately establish and implement procedures, specifically lacking documented approvals for critical manufacturing procedures and software validation plans for RTA machines. This indicates a moderate severity issue concerning the firm's quality system.