FDA Inspection 814566 — Promethean LifeSciences, Inc.
The FDA completed an inspection of Promethean LifeSciences, Inc. on January 11, 2013 in Pittsburgh, PA. 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
- January 11, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Pittsburgh, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12323 | 21 CFR 1271.160(b)(5) | Monitoring systems |
| 12354 | 21 CFR 1271.190(d)(2) | Documentation of activities |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |