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X-Spine incurs FDA wrath over GMP faults

This article was originally published in Clinica

Executive Summary

Spinal implant specialist X-Spine is under scrutiny from the US FDA due to several alleged violations of good manufacturing practice (GMP). According to a warning letter posted on the FDA’s website on August 15, an inspection of the firm’s Miamisburg, Ohio facility in April this year, revealed that, among other things, X-Spine was guilty of suspected failures in supplier agreements, quality specifications, and complaint handling procedures. The US watchdog highlighted the firm’s Spider cervical plating system as an offending product, claiming that X Spine revised the package insert for the product without notifying any customers of a potential change in sterility assurance levels. X-Spine has 15 days to reply to the warning letter.

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