FDA Inspection 1237108 — Regional Women's Health Group, LLC
The FDA completed an inspection of Regional Women's Health Group, LLC on April 29, 2024 in Marlton, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 29, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Marlton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |