FDA Inspection 911592 — Ascension Saint Thomas Hospital Midtown
The FDA completed an inspection of Ascension Saint Thomas Hospital Midtown on December 15, 2014 in Nashville, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 15, 2014
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Nashville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3955 | 21 CFR 58.63(b) | Equipment: maintenance SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |