FDA 483 - Helen L. Stacey M.D. - April 01, 2025

An FDA inspection of Helen L. Stacey M.D. in Walnut Creek, CA, a clinical investigator, identified a failure to maintain adequate case histories for clinical trial subjects. This deficiency involved incomplete documentation of administrative and systemic reactions, as well as missing subject diaries, indicating significant issues with data integrity and record-keeping for investigational studies.