FDA inspection
Baylor St Luke's Medical Center IRB & Research: FDA inspection ending Aug 14, 2014
FDA inspection 890591 · Voluntary Action Indicated (VAI) · Houston, TX
Key facts
| Inspection ID | 890591 |
|---|---|
| Firm | Baylor St Luke's Medical Center IRB & Research |
| FEI number | 1641343 |
| Address | 6720 Bertner St, MC 3-288 (5th Floor, Room O-510) |
| City | Houston |
| State | TX |
| ZIP | 77030 |
| Country | United States |
| Fiscal year | 2014 |
| Inspection end date | Aug 14, 2014 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Bioresearch Monitoring |
| Product type | Biologics |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data