# FDA 483 - Stephen Fallon PhD - June 13, 2025

Source: https://www.keypedia.com/records/483/stephen-fallon-phd/1b0cb226-e829-4e92-aab4-194806aabd3a

> FDA 483 for Stephen Fallon PhD on June 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stephen Fallon PhD
- Inspection Date: 2025-06-13
- Product Type: drugs
- Office Name: Florida District Office
- Summary: An FDA inspection of Stephen J. Fallon PHD, a clinical investigator in Wilton Manors, FL, revealed significant deficiencies in the documentation of informed consent for a clinical study. The primary finding was that informed consent forms were not properly signed or dated by subjects or their legally authorized representatives, and in one instance, consent was not obtained prior to screening activities.

## Related Officers

- [investigator](https://www.keypedia.com/people/emily-c-caldwell/101868aa-0586-4d37-8bc6-194f43d66cb7)
- [Ricardo Vela](https://www.keypedia.com/people/ricardo-vela/b090df1e-9d71-423a-9ec8-efaaaff5dda3)

Company: https://www.keypedia.com/companies/stephen-fallon-phd/07067260-a278-4911-997d-3ff028642b8a

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9