FDA Inspection 886734 — CCRM DFW
The FDA completed an inspection of CCRM DFW on July 10, 2014 in Frisco, TX. 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
- July 10, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Frisco, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |