FDA Inspection 960958 — VACT Healthcare System
The FDA completed an inspection of VACT Healthcare System on Mar 7, 2016 in West Haven, CT. 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
- Mar 7, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- West Haven, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 113 | 21 CFR 606.121(b) | Collection/initial processing facility labels |
| 137 | 21 CFR 606.121(c)(13) | Unapproved encoded/machine readable information |
| 95 | 21 CFR 606.100(b)(16) | Labeling procedures to avoid labeling mix-ups |