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•Donald M Brandon MD•February 24, 2023

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

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Record Details

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.

Company
Donald M Brandon MD
Inspection Date
February 24, 2023
Product Type
Drugs
Office
Division of Pharmaceutical Quality Operations IV
Person
  • Denise L. Burosh (Bioresearch Monitoring Specialis)
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ID · f994bc00-f095-438c-be6e-440f89841944

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