Gynetech received a Form 483 for untimely reporting procedures, risk analyses that were not performed, and 12 other observations.
FDA inspectors visited the company’s Richmond, Virginia, facility in September 2016 and found that a medical device report was not submitted within 30 days of receiving complaints that its Manipulator and Manipulator Pro surgical devices had seriously malfunctioned and caused surgical complications.
They also found that the firm had failed to document design risk analysis of the devices before a certain date. In addition, the firm’s procedures required high-risk suppliers to be audited, but no audit criteria had been established.
Gynetech also was observed not to have established design transfer procedures. Design transfers of the devices were not documented during certain design projects.
The Form 483 additionally noted that customer complaint procedures did not ensure timely and uniform processing. None of the complaint records reviewed contained an adequate determination of whether a complaint indicated malfunctions that could likely contribute to a death or serious injury.
Auditors also observed that the firm lacked a medical device reporting procedure and had not adequately established plans that described or referenced design and development activities and defined responsibility for their implementation.
Other observations included a lack of procedures for addressing incomplete, ambiguous, or conflicting design input requirements, and inadequate procedures for design review, management review, and auditing.