Medtronic Navigation was handed a six-observation Form 483 for issues related to CAPA, supplier investigations and quality inspections.
For example, the company had not validated accuracy acceptance testing for its S7 Surgeon Touch Monitor, which helps locate anatomical structures in open or percutaneous procedures. Medtronic classified the testing as a business need, rather than a user need, according to the form. However, the FDA’s review of complaint files for 2013 showed six that appeared to report accuracy issues with the monitor.
FDA investigators also reviewed five nonconformance reports, finding three that lacked documentation of a supplier investigation. While the company’s procedure states reworked material must be reinspected, an NCR requiring rework lacked documentation of a reinspection.
Meanwhile, the company’s standard operating procedure for unused, returned product did not state when a quality inspection of the product is necessary or address the disposition of returned goods. The investigators reviewed returned goods authorizations, finding six where products were returned to inventory with no documentation of inspection, testing or other verification.
They also reviewed documentation on the initial validation of the GoldenEye Calibration Robot, finding nothing on challenge tests for worst-case conditions or performance under a variety of process parameters.
Medtronic’s CAPA procedure also drew investigators’ attention. According to the procedure, once a CAPA has moved into the action execution phase, it can no longer receive a “no further action required” designation. However, two CAPA files with documentation of actions were classified as “closed-no action” and no effectiveness checks were performed, the form says.
Moreover, the company’s procedure states that CAPA timeliness is ensured by monitoring the progression of the CAPA phases, but eight files had investigation initiation dates 30 days or more after the creation log date of the CAPA file, the Form 483 adds.
Medtronic did not provide a comment on the Form 483.
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