# FDA 483 - William Wierda,, M.D. - December 21, 2015

Source: https://www.keypedia.com/records/483/william-wierda-md/84ab61d6-4ed1-4a16-b2a8-34fe5b32d715

> FDA 483 for William Wierda,, M.D. on December 21, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: William Wierda,, M.D.
- Inspection Date: 2015-12-21
- Product Type: drugs
- Office Name: Division of Southwest Imports
- Summary: An FDA inspection of William G. Wierda, M.D., a clinical investigator in Houston, TX, identified critical failures in the timely reporting of serious adverse events to the study sponsor. The firm did not adhere to protocol requirements for notifying the sponsor about significant incidents, including a subject's death, a cardiac procedure, and a hip fracture. These lapses indicate a serious deficiency in clinical trial oversight and subject safety reporting.

## Related Officers

- [investigator](https://www.keypedia.com/people/zerita-white/82b19f0c-bd17-4a44-8523-8986f38851a8)
- [Zerita Bomani-S](https://www.keypedia.com/people/zerita-bomani-s/decdf9ea-9cb5-4530-a5ce-be0e1f7deea9)

Company: https://www.keypedia.com/companies/william-wierda-md/d25248e0-1fdc-4ca5-ba6d-daef385d9fe6

Office: https://www.keypedia.com/offices/division-of-southwest-imports/1a990c0f-8880-49cd-9fdf-e7e450072e5a