FDA Inspection 1078912 — Emerson Health Hospital
The FDA completed an inspection of Emerson Health Hospital on February 4, 2019 in Concord, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 4, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Concord, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 181 | 21 CFR 610.53(b) | Dating periods for licensed biological products |