FDA Inspection 933297 — Pacific Reproductive Center, Inc.
The FDA completed an inspection of Pacific Reproductive Center, Inc. on Jul 6, 2015 in Irvine, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 6, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |
| 12232 | 21 CFR 1271.50(b)(2) | Donor testing not negative for CD agents |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |