FDA Inspection 621582 — Helen Mintz-Hittner, M.D.
The FDA completed an inspection of Helen Mintz-Hittner, M.D. on October 14, 2009 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 14, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Houston, TX (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7517 | 21 CFR 312.66 | Initial and continuing review |
| 7666 | 21 CFR 50.20 | Understandable language |