FDA Cites OsteoSymbionics for Procedural Failures

Devicemaker OsteoSymbionics must correct several problems uncovered by FDA investigators, including CAPA procedures and non-conforming materials reports (NCMRs).

The FDA issued the company a Form 483 after a March inspection of its Cleveland facility. The inspection found the firm had not completed a CAPA opened in June 2015. Moreover, according to the form, the company’s NCMRs did not clearly document all investigative activities as required by the company’s own procedures. Ten of 14 NCMRs reviewed did not document why no investigation was required, and three had no information in the investigation and approval sections.

In addition, the company’s supplier files did not comply with the firm’s Supplier Evaluation and Selection SOPs, according to investigators, with several missing components such as evaluation records, up-to-date ISO certifications and supplier quality monitoring.

Lastly, according to the FDA, a heat sealer used for sterile packaging of the company’s cranial implants was calibrated for time and temperature but not for pressure, with the last calibration occurring nearly two years ago.