Vilex Warned for Adulterated Products

The FDA hit Vilex in Tennessee with a warning letter for producing adulterated medical device products at its McMinnville facility.

The company did not properly document design history files for multiple class II medical devices, including its Met-Head Implant, Vilex Bone Plate System, Dual Thread Bone Screw and Cannulated Hemi Toe Implant.

It also failed to confirm that all purchased products conformed to requirements. Its purchasing procedure was ruled inadequate because it did not ensure that suppliers of unverifiable critical processes were evaluated on their ability to meet specified requirements. The firm qualified its suppliers based only on ISO certifications.