FDA Inspection 840142 — Regional Women's Health Group, LLC
The FDA completed an inspection of Regional Women's Health Group, LLC on July 11, 2013 in Marlton, NJ. 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
- July 11, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Marlton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12232 | 21 CFR 1271.50(b)(2) | Donor testing not negative for CD agents |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |