FDA Inspection 748100 — Steven W. Boyce, M. D.
The FDA completed an inspection of Steven W. Boyce, M. D. on September 15, 2011 in Washington, DC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 15, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Washington, DC (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7517 | 21 CFR 312.66 | Initial and continuing review |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |