Turbo Wheelchair failed to maintain device master records, complaint files or MDR procedures, according to the FDA.
The agency issued a Form 483 following an April/May inspection of the firm’s Louisville, Ky., facility. The company had no device master records for three of the five devices it manufactured, and the records it did maintain failed to reflect current specifications.
The company also did not maintain adequate device history records. The manufacturing records the company president provided consisted of a checklist to aid in assembling the devices, with no specifics for labeling or DMR compliance.