FDA Inspection 886807 — North Carolina Center for Reproductive Medicine Inc (NCCRM)
The FDA completed an inspection of North Carolina Center for Reproductive Medicine Inc (NCCRM) on July 11, 2014 in Cary, NC. 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
- July 11, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Cary, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |