FDA Inspection 1073386 — Northern Light Eastern Maine Medical Center
The FDA completed an inspection of Northern Light Eastern Maine Medical Center on December 3, 2018 in Bangor, ME. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 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 |