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

Source: https://www.globalkeysolutions.net/records/483/odyssey-medical-technologies-llc/9adf4768-6bf5-41cd-b1af-5ca1a941a44f

> FDA 483 for Odyssey Medical Technologies, LLC. on April 03, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Odyssey Medical Technologies, LLC.
- Inspection Date: 2023-04-03
- Product Type: device
- Office Name: New Orleans District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/nikki-s-bryant/fe859d4f-23a6-4bc9-94c6-5b3c3fe8d99a)

Company: https://www.globalkeysolutions.net/companies/odyssey-medical-technologies-llc/def3af63-9b0c-430d-beda-9368a67cc059

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea