# FDA 483 - Full Range Rehab LLC - January 31, 2019

Source: https://www.globalkeysolutions.net/records/483/full-range-rehab-llc/47a90a82-a02f-41cf-9ec4-e93bf482589e

> FDA 483 for Full Range Rehab LLC on January 31, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Full Range Rehab LLC
- Inspection Date: 2019-01-31
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Full Range Rehab LLC, a medical device manufacturer in Cincinnati, OH, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for critical processes such as MDR reporting, CAPA, quality audits, complaint handling, device history records, and device master records. Many of these issues were repeat observations from a previous inspection, indicating a persistent lack of compliance.

## Related Documents

- [483 - 2023-07-28](https://www.globalkeysolutions.net/records/483/full-range-rehab-llc/42a57bc8-c923-4bbc-b0fc-1860be47c7bb)

## Related Officers

- [Consumer Safety Officer, Medical Device Specialist](https://www.globalkeysolutions.net/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)

Company: https://www.globalkeysolutions.net/companies/full-range-rehab-llc/80c9d80e-b15f-4db1-97ed-25f0a986395e

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