483
Odyssey Medical Technologies, LLC.Odyssey Medical Technologies, LLC. – FDA 483, Apr 3, 2023
Record Details
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.
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ID · 9adf4768-6bf5-41cd-b1af-5ca1a941a44f
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