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483
•Odyssey Medical Technologies, LLC.•April 3, 2023

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

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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.

Company
Odyssey Medical Technologies, LLC.
Inspection Date
April 3, 2023
Product Type
Device
Office
New Orleans District Office
Person
  • Nikki S. Bryant (investigator)
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ID · 9adf4768-6bf5-41cd-b1af-5ca1a941a44f

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