# FDA 483 - William G. P. Eardley, MSc, MD - July 06, 2018

Source: https://www.globalkeysolutions.net/records/483/william-g-p-eardley-msc-md/24cc888b-9ed6-412a-9e51-d66e840f34d4

> FDA 483 for William G. P. Eardley, MSc, MD on July 06, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: William G. P. Eardley, MSc, MD
- Inspection Date: 2018-07-06
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of William G. P. Eardley, MSC, MD, FRCSED, Clinical Investigator, revealed significant issues with a clinical investigation. The firm failed to conduct the study according to the investigational plan, including not collecting required data, improperly documenting a serious adverse event, and enrolling an ineligible subject. Additionally, informed consent was not properly obtained or documented for a study subject.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sandra-saniga/a1a89397-a095-46de-9355-aa1cd88d729a)

Company: https://www.globalkeysolutions.net/companies/william-g-p-eardley-msc-md/257b417d-aea3-4c0e-8cc5-62ae4170108a

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd