# FDA 483 - Bryan Medical Inc - July 23, 2021

Source: https://www.globalkeysolutions.net/records/483/bryan-medical-inc/6585f80c-d512-4152-be25-535291f52e40

> FDA 483 for Bryan Medical Inc on July 23, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bryan Medical Inc
- Inspection Date: 2021-07-23
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Bryan Medical Inc, a medical device manufacturer in Cincinnati, OH, was cited for three observations during an FDA inspection. The firm failed to adequately establish procedures for design transfer and design validation for its Aeris Catheters, leading to issues with product distribution and testing. Additionally, the firm's complaint management procedures were found to be inadequate, with an uninvestigated complaint and unclear handling of complaints for foreign-manufactured products.

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.globalkeysolutions.net/companies/bryan-medical-inc/795fa29c-c9c4-4778-b160-94a1367e6350

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