# FDA 483 - Francis P. Worden, M.D. - April 04, 2023

Source: https://www.globalkeysolutions.net/records/483/francis-p-worden-md/68e0530e-165a-4bbf-8998-2a418e9529c6

> FDA 483 for Francis P. Worden, M.D. on April 04, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Francis P. Worden, M.D.
- Inspection Date: 2023-04-04
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Francis P. Worden, M.D., a clinical investigator in Ann Arbor, MI, revealed a significant deviation from an investigational plan. The firm failed to ensure subjects met eligibility criteria prior to enrollment, randomization, and treatment with investigational product. This indicates a serious lapse in adherence to study protocols.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/dina-a-tallman/e9bf2b98-6697-4d7c-9052-84339536acfd)

Company: https://www.globalkeysolutions.net/companies/francis-p-worden-md/532a719e-8d82-49cd-b087-95959ff895a1

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0