# FDA 483 - Ekso Bionics Inc. - December 21, 2023

Source: https://www.globalkeysolutions.net/records/483/ekso-bionics-inc/876a0850-588c-4292-8a8e-d79b675306d6

> FDA 483 for Ekso Bionics Inc. on December 21, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ekso Bionics Inc.
- Inspection Date: 2023-12-21
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: During an inspection, Ekso Bionics Inc. in Macedonia, OH, a medical device manufacturer, was cited for inadequate procedures to control nonconforming product. The firm's procedures failed to clearly define the assignment and use of nonconforming codes for data analysis and lacked a system to link nonconformances to process risk analysis. This indicates a significant deficiency in their quality management system.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.globalkeysolutions.net/companies/ekso-bionics-inc/55ee5f44-99f8-4ae2-aa66-6863f4a79e83

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22