FDA Inspection 565102 — DCI Donor Services
The FDA completed an inspection of DCI Donor Services on January 30, 2009 in Albuquerque, NM. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 30, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Albuquerque, NM (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |