Failure to review and evaluate all complaints and maintain a record of the reason no investigation was made and the name of the individual responsible for the decision not to investigate; failure to maintain records that demonstrate that each batch, lot, or unit of device meets in-process or finished device specifications; failure to validate and document all processes and/or off-the-shelf software used to operate and control equipment; failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications; failure to maintain and implement written Medical Device Reporting procedures; and failure to report within 30 days information that suggests that a device has malfuntioned.
Failure to validate and document all processes and/or off-the-shelf software used to operate and control equipment, which cannot be fully verified by subsequent inspection with a high degree of assurance, which is approved according to established procedures, as required by 21 CFR 820.75(a) . For example, polishing validation fails to document adequate results for single and multi-piece lenses including polishing, tumbler speed, duration, and re-polishing of reworked lenses, off-the-shelf software use for the operation of the DAC lathe and to trend quality data related to nonconformances (FDA 483, Item #6 & #9).
