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

Source: https://www.globalkeysolutions.net/records/483/helen-l-stacey-md/7fe2a84d-cfcc-443e-b0c0-7485a1cf0ddf

> FDA 483 for Helen L. Stacey M.D. on April 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Helen L. Stacey M.D.
- Inspection Date: 2025-04-01
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: 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.

## Related Officers

- [FDA_PERSONNEL](https://www.globalkeysolutions.net/people/stephanie-barragan/fc1bc901-1467-4fdd-bee3-f87f2db3a1fa)

Company: https://www.globalkeysolutions.net/companies/helen-l-stacey-md/2a10fd55-30bc-459d-af47-92a04c49ecca

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df