# FDA 483 - Full Range Rehab LLC - July 28, 2023

Source: https://www.keypedia.com/records/483/full-range-rehab-llc/42a57bc8-c923-4bbc-b0fc-1860be47c7bb

> FDA 483 for Full Range Rehab LLC on July 28, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Full Range Rehab LLC
- Inspection Date: 2023-07-28
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: During an inspection, Full Range Rehab LLC, a medical device manufacturer in West Chester, OH, was cited for multiple deficiencies in its quality system. Observations included inadequate procedures for corrective and preventive actions, lack of software validation, and insufficient controls for product identification, equipment calibration, incoming product acceptance, and contractor evaluation. These issues indicate a systemic failure to establish and follow essential quality management processes.

## Related Documents

- [483 - 2019-01-31](https://www.keypedia.com/records/483/full-range-rehab-llc/47a90a82-a02f-41cf-9ec4-e93bf482589e)

## Related Officers

- [Consumer Safety Officer, Medical Device Specialist](https://www.keypedia.com/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)
- [Amber M. Capello-Jones](https://www.keypedia.com/people/amber-m-capello-jones/d34f92a0-d580-4028-9d31-c6cd7c13ce0f)

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

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