FDA Inspection 864897 — VACT Healthcare System
The FDA completed an inspection of VACT Healthcare System on Jan 30, 2014 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
- Jan 30, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- West Haven, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2087 | 21 CFR 211.208 | Salvaging performed without evidence |
| 9087 | 21 CFR 600.14(a)(1) | Who must report - receiving information |
| 98 | 21 CFR 606.100(c) | Thorough investigations |