FDA: Innovative Neurotronics' response to warning letter incomplete
Device Regulation Alert: Safety, Compliance and Reimbursement News, December 15, 2008
Innovative Neurotronics did not completely resolve problems uncovered by an FDA inspection, according to an FDA warning letter.
FDA inspectors determined that Innovative Neurotronics failed to follow current Good Manufacturing Practices in its Austin, TX, facility where it manufacturers the WalkAide System, an external functional neuromuscular stimulator. The agency acknowledged the company’s commitment to improving its compliance efforts, but said Innovative Neurotronics has not implemented a formal quality plan to improve the quality of its devices and verified the plan’s effectiveness.
The FDA said it plans to work closely with the company to improve device quality and will conduct follow-up inspections.
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