FDA Inspection 700475 — Conceptions Reproductive Associates
The FDA completed an inspection of Conceptions Reproductive Associates on December 1, 2010 in Highlands Ranch, 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
- December 1, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Highlands Ranch, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12334 | 21 CFR 1271.170(c) | Trained or re-trained as necessary |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |