Acuity Surgical Devices, LLC – FDA 483, May 20, 2019

An FDA inspection of Reflexy Surgical Devices, LLC in Irving, TX, identified significant deficiencies in the firm's quality system. Observations included a lack of internal audits for three consecutive years, inadequate documentation of personnel training, and the absence of established procedures for equipment calibration. These issues indicate a failure to ensure compliance with quality system procedures and proper control over critical manufacturing processes.