FDA 483 - R-Med Inc - February 23, 2018

R-Med Inc. in Oregon, OH, a medical device manufacturer, was inspected and received 11 observations. The inspection revealed significant deficiencies across its quality system, including inadequate control of nonconforming product, poor complaint handling, and a complete lack of design history files, risk analysis, device history records, and device master records for its disposable plugs. The firm also lacked established procedures for design changes, incoming product acceptance, statistical techniques, quality audits, and management reviews, indicating a pervasive failure to maintain a suitable and effective quality system.