FDA Inspection 916284 — Emerson Health Hospital
The FDA completed an inspection of Emerson Health Hospital on Jan 13, 2015 in Concord, MA. 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 13, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Concord, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |