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Vilex Warned for Manufacturing Adulterated Medical Devices

March 30, 2018

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.

The firm stated in its response to a Form 483 report that some of the devices may have all of the documentation for a design history file in their 510(k) file, but the response was deemed inadequate because it did not indicate which devices it was referencing.

The agency noted the firm’s failure to adequately establish design validation procedures — for example, engaging in validation activities two years before the validation protocol was approved. The agency found Vilex’s response inadequate because it lacked updated procedures, evidence of training or reviews of previous and current design history files.

The firm 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.

The agency found the firm’s response inadequate because it did not address training requirements related to updated forms and procedures.

The investigator also noted the firm’s failure to rework and reevaluate entries in the device history record. The rework the firm claimed to have committed had no documentation in the DHR.

The agency said the facility’s response was inadequate because it did not indicate a review of the system and of other potentially reworked products.

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