# FDA 483 - Kathleen M. Mullane, D.O. - October 20, 2020

Source: https://www.keypedia.com/records/483/kathleen-m-mullane-do/c6311e01-4867-4ec5-852f-fc353f2dff8a

> FDA 483 for Kathleen M. Mullane, D.O. on October 20, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kathleen M. Mullane, D.O.
- Inspection Date: 2020-10-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East VI
- Summary: Kathleen M. Mullane, Clinical Investigator, was inspected by the FDA, revealing significant deviations from investigational plans and inadequate record-keeping. The inspection found instances where study drugs were administered contrary to protocol, prohibited medications were given, and eligibility assessments were not properly documented. Additionally, serious adverse events were not reported to the sponsor within the required timeframe, and case histories lacked essential data.

## Related Officers

- [Debra L. Boyd-Seale](https://www.keypedia.com/people/debra-l-boyd-seale/6f9af6f9-8deb-494d-b73e-fca63b95d7d2)

Company: https://www.keypedia.com/companies/kathleen-m-mullane-do/da04793b-5898-4738-b698-4f682c6faaac

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