FDA Inspection 1044808 — Plasma Services Group, Inc
The FDA completed an inspection of Plasma Services Group, Inc on Mar 15, 2018 in Moorestown, NJ. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 15, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Moorestown, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 114 | 21 CFR 606.121(c)(1) | Proper name of product |
| 123 | 21 CFR 606.121(c)(4)(i) | Expiration date |
| 15079 | 21 CFR 606.121(c)(11) | Required labeling information - manufacturing use |
| 15080 | 21 CFR 606.121(c)(12) | Labeling; test results for rel transmitted infections |