FDA EIR - Illuminoss Medical Inc. - September 24, 2019

An FDA inspection of IlluminOss Medical Inc., conducted from September 17-24, 2019, identified significant deficiencies in the company's compliance with medical device Quality System Regulations, primarily 21 CFR Part 803 and 820. The inspection highlighted six main violations. These included failing to submit critical Medical Device Reports (MDRs) within the required 5-day and 30-day timeframes, even when remedial actions were necessary due to a device malfunction. Inspectors also found inadequate control and documentation of nonconforming products identified during manufacturing. Furthermore, IlluminOss Medical Inc. failed to adequately qualify and approve key suppliers for components like plastic light pipe fibers and reamers, impacting product conformity. The company also used unverified inspection and testing equipment for qualifying critical production fixtures. Finally, procedures for receiving, reviewing, and evaluating customer complaints for MDR reportability were deemed insufficient, with several complaints not adequately investigated or documented. Management acknowledged these objectionable conditions and committed to submitting a written response to FDA within 30 calendar days, detailing corrective actions for all observations.