# FDA 483 - Bluewater Diagnostic Laboratory - October 13, 2022

Source: https://www.globalkeysolutions.net/records/483/bluewater-diagnostic-laboratory/b456b7cb-eed8-4380-bcb1-f5c6cea71de9

> FDA 483 for Bluewater Diagnostic Laboratory on October 13, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bluewater Diagnostic Laboratory
- Inspection Date: 2022-10-13
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: Bluewater Diagnostic Laboratory, a clinical investigator in Mount Washington, KY, received a Form 483 with five observations following an FDA inspection. The findings indicate significant issues with the conduct of a clinical study, including failures in adhering to investigational plans, obtaining proper informed consent, maintaining complete and accurate subject records, and ensuring IRB approval for study amendments. These deficiencies highlight a lack of control over critical aspects of human subject protection and data integrity in clinical research.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/anthony-j-grace/023993d4-63ef-40ba-a538-42479b65011c)

Company: https://www.globalkeysolutions.net/companies/bluewater-diagnostic-laboratory/5c2b4fe3-8108-4df2-8023-6bbe84bcdb9b

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