FDA Inspection 1075337 — Rachael A. Callcut, M.D., M.S.P.H.
The FDA completed an inspection of Rachael A. Callcut, M.D., M.S.P.H. on Dec 13, 2018 in San Francisco, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 13, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- San Francisco, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7393 | 21 CFR 50.25(a)(8) | Participation; refusal and discontinuance |