FDA Inspection 728860 — Reproductive Sciences Medical Center, Inc.
The FDA completed an inspection of Reproductive Sciences Medical Center, Inc. on June 10, 2011 in San Diego, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 10, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12225 | 21 CFR 1271.47(d) | Departures: recording and justifying |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |