FDA EIR - Sterling Diagnostics, Inc. - July 28, 2016

An FDA comprehensive inspection of Sterling Diagnostics, Inc. was conducted from July 6-28, 2016, to assess compliance with the Quality System Regulation (21 CFR Part 820) for medical device manufacturers. The inspection identified ten significant deficiencies, leading to the issuance of a Form FDA 483. Key violations included the failure to adequately validate critical manufacturing processes, such as mixing and cleaning for in vitro diagnostic test kits, and the lack of proper validation for packaging designs intended to maintain specified storage temperatures during shipment. The company also lacked established procedures for managing design changes, notably extending product shelf-life without supporting data, which resulted in a voluntary recall initiated during the inspection. Further issues involved incomplete complaint records, insufficient evaluation of complaints for investigations, and inaccuracies in Device History and Master Records. Additionally, the inspection found temperature control problems in a cold storage room and an absence of procedures for nonconforming products. Sterling Diagnostics, Inc. committed to providing a comprehensive corrective action plan to the Detroit District Office within fifteen business days.