# FDA 483 - Donald M Brandon MD - February 24, 2023

Source: https://www.keypedia.com/records/483/donald-m-brandon-md/f994bc00-f095-438c-be6e-440f89841944

> FDA 483 for Donald M Brandon MD on February 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Donald M Brandon MD
- Inspection Date: 2023-02-24
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Donald M Brandon MD in San Diego, CA, revealed a significant issue regarding the maintenance of accurate case histories and informed consent. The firm failed to maintain essential medical history, source records, and signed informed consent for a subject enrolled and dosed in the Sanofi Pasteur Inc. MET50 study. This indicates a serious lapse in record-keeping and patient protection protocols.

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- [Bioresearch Monitoring Specialis](https://www.keypedia.com/people/denise-l-burosh/075a442f-67e0-4a65-9c09-e8819a329773)

Company: https://www.keypedia.com/companies/donald-m-brandon-md/54f95d50-3024-4fc7-b31c-4d8ac997e01d

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6