FDA Inspection 1073386 — Northern Light Eastern Maine Medical Center
The FDA completed an inspection of Northern Light Eastern Maine Medical Center on Dec 3, 2018 in Bangor, ME. 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
- Dec 3, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Bangor, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 150 | 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 9225 | 21 CFR 606.171 | Biological product deviation report |