Nuvasive received a Form 483 for failing to establish adequate corrective and preventive action (CAPA) procedures and failing to document process validation activities and results.
After an October 2016 inspection of Nuvasive’s Fairborn, Ohio, facility, inspectors reported problems with the company’s CAPA procedures. In particular, one out of 11 CAPAs reviewed did not include an effectiveness check.
In addition, a preventive action report was opened to correct an internal audit observation that retrospective validations did not have required information. The preventive action report was closed with no documented efficacy testing. The PAR also did not meet the definition of a preventive action because it was opened to correct a deficiency found during the internal audit.