FDA Inspection
Northern Light Eastern Maine Medical CenterNorthern Light Eastern Maine Medical Center – FDA Inspection, Dec 3, 2018
Record Details
This FDA Inspection record concerns Northern Light Eastern Maine Medical Center, with an inspection on December 3, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 3, 2018
- Product Type
- Biologics
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ID · bb804404-df12-4460-a79f-a4f1223fdcd2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1073386
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
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Other FDA inspections of Northern Light Eastern Maine Medical Center
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 6, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 23, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 7, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 12, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Northern Light Eastern Maine Medical Center
- FDA Inspection 1265017 - 2025-03-13
- FDA Inspection 1176606 - 2022-07-06
- FDA Inspection 1005178 - 2017-03-23
- FDA Inspection 926836 - 2015-04-07
- FDA Inspection 822010 - 2013-03-12
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