FDA 483 - Odyssey Medical Technologies, LLC. - April 03, 2023

An FDA inspection of Odyssey Medical Technologies, LLC. in Bartlett, TN, from March 28 to April 3, 2023, revealed a significant issue with complaint investigation documentation. The firm failed to complete required forms for complaint evaluations and investigations for Class II medical devices in a majority of reviewed cases. This indicates a lapse in ensuring proper record-keeping for product non-conformances.