FDA Inspection 900074 — Anna Klukowska, University Med School in Warsaw,
The FDA completed an inspection of Anna Klukowska, University Med School in Warsaw, on September 19, 2014 in Warsaw. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 19, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Warsaw (Poland)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7657 | 21 CFR 50.25(b)(5) | Significant new findings |