Zynex Medical, Inc – FDA EIR, Jun 15, 2022

An FDA routine surveillance inspection of Zynex Medical, Inc. (ZMI), a medical device manufacturer based in Englewood, CO, was conducted from June 8 to June 15, 2022. The inspection, performed under Compliance Program 7382.845 for Medical Device Manufacturers, assessed ZMI's comprehensive Quality System, including Management Controls, Design Controls, Corrective and Preventive Actions (CAPA), and Production and Process Controls. During the inspection, the FDA identified four significant quality system deficiencies, detailed in an FDA Form 483. The main issues included inadequately established procedures for: 1) Corrective and Preventive Actions, where CAPA records lacked sufficient documentation for effectiveness verification plans and objective supporting evidence (21 CFR 820.100(a)). 2) Rework of Nonconforming Product, as the firm failed to maintain records of final acceptance testing for reworked devices (21 CFR 820.90(b)(2)). 3) Acceptance of Incoming Product, noting an insufficient sampling size during receiving inspection for a lot of components, which did not comply with their established sampling plan (21 CFR 820.80(b)). 4) Quality Audits, where an internal audit was conducted by a Quality Assurance Specialist of their own department's records, indicating a lack of auditor independence (21 CFR 820.22). Additionally, the FDA noted that calibration procedures lacked a requirement for traceability to established standards. In response to the FDA 483 observations, Zynex Medical, Inc.'s Chief Operating Officer acknowledged understanding and provided a "promise to correct" for all noted deficiencies, committing to submit a detailed correction timetable. The company was also informed of potential regulatory sanctions.