FDA Inspection 830018 — Burzynski Research Institute
The FDA completed an inspection of Burzynski Research Institute on March 15, 2013 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 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
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7554 | 21 CFR 312.53(c)(4) | Financial information - sufficient and accurate |