FDA Inspection 829348 — Stanislaw R Burzynski, MD
The FDA completed an inspection of Stanislaw R Burzynski, MD on March 15, 2013 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 15, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Houston, TX (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |
| 7385 | 21 CFR 50.25(b)(3) | Possible additional costs to the subject |
| 7498 | 21 CFR 312.66 | Unanticipated problems |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |