Sterling Diagnostics, Inc. – FDA EIR, Jul 28, 2016

An FDA inspection of Sterling Diagnostics, Inc., a medical device manufacturer in Sterling Heights, MI, was conducted from July 6-28, 2016. This comprehensive Quality System Inspection Technique (QSIT) assessed compliance with the Quality System Regulation. The inspection revealed ten significant violations, leading to the issuance of an FDA Form 483. Key issues included the failure to validate critical manufacturing processes, such as mixing and cleaning, and inadequate validation of packaging designed to maintain required storage temperatures during product shipment. The company also lacked established procedures for design changes, notably extending product shelf lives from 24 to 36 months without supporting data or documentation. Further observations detailed incomplete and improperly evaluated complaint records, acceptance of components based on incomplete specifications, obsolete Device Master Records, and temperature control deficiencies in a cold room. A procedure for nonconforming product was also absent. Sterling Diagnostics management committed to submitting a corrective action plan to the Detroit District Office within fifteen business days. Additionally, a voluntary recall was initiated during the inspection to address the unvalidated shelf-life extensions.