# FDA 483 - Patrick J. Stiff, M.D. - August 01, 2022

Source: https://www.globalkeysolutions.net/records/483/patrick-j-stiff-md/a4a5711b-febd-4241-b6f7-d7f9b08904cf

> FDA 483 for Patrick J. Stiff, M.D. on August 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patrick J. Stiff, M.D.
- Inspection Date: 2022-08-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East VI
- Summary: The FDA inspected Patrick J. Stiff, MD, Clinical Investigator in Maywood, IL, and identified three significant deficiencies in the conduct of a clinical trial. Observations included a failure to adhere to the investigational plan by enrolling a subject without required study chair consultation, improper informed consent documentation due to the use of an unapproved form, and a lack of necessary signatures on short form consent summary documents. These findings indicate serious issues with protocol adherence and informed consent processes.

## Related Officers

- [Rachel E Mcguigan](https://www.globalkeysolutions.net/people/rachel-e-mcguigan/da725842-7858-402e-a99c-71a4b95dd8e1)
- [Debra L. Boyd-Seale](https://www.globalkeysolutions.net/people/debra-l-boyd-seale/6f9af6f9-8deb-494d-b73e-fca63b95d7d2)

Company: https://www.globalkeysolutions.net/companies/patrick-j-stiff-md/59ea29e9-a8ce-4417-97f5-858e424a9406

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-vi/4a1cadca-f04c-44d0-8d7a-4e1d6e583766