FDA Inspection 577659 — Promethean LifeSciences, Inc.
The FDA completed an inspection of Promethean LifeSciences, Inc. on April 28, 2009 in Pittsburgh, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 28, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Pittsburgh, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12315 | 21 CFR 1271.160(b)(2) | Sharing of information (general) |
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |