FDA Inspection 650311 — Donor Alliance, Inc.
The FDA completed an inspection of Donor Alliance, Inc. on March 4, 2010 in Denver, CO. 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
- March 4, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12309 | 21 CFR 1271.160(a) | Program is appropriate for the HCT/Ps |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |
| 12444 | 21 CFR 1271.270(e) | Contract firms--identities and responsibilities |