FDA Inspection 631785 — Conceptions Reproductive Associates
The FDA completed an inspection of Conceptions Reproductive Associates on December 10, 2009 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 10, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Highlands Ranch, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |