# FDA 483 - Riverain Technologies Inc - September 14, 2021

Source: https://www.keypedia.com/records/483/riverain-technologies-inc/449c626f-6399-419d-8ba1-1763dbcb2307

> FDA 483 for Riverain Technologies Inc on September 14, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Riverain Technologies Inc
- Inspection Date: 2021-09-14
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Riverain Technologies Inc., a medical device manufacturer in Miamisburg, OH, was cited for four observations during an FDA inspection. The observations primarily concern inadequate procedures for design changes, corrective and preventive actions, control of nonconforming product, and acceptance of incoming product. These issues indicate significant deficiencies in the firm's quality system.

## 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/riverain-technologies-inc/28cc0768-f9e7-470e-b782-ba2213cd2084

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