FDA Inspection
Legacy Emanuel Medical CenterLegacy Emanuel Medical Center – FDA Inspection, Oct 9, 2015
Record Details
This FDA Inspection record concerns Legacy Emanuel Medical Center, with an inspection on October 9, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 9, 2015
- Product Type
- Biologics
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ID · d81155c7-4208-426c-a80c-753af1dcb763
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 945478
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 640.11(a)General requirements - storage
- 21 CFR 606.171Biological product deviation report
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Other FDA inspections of Legacy Emanuel Medical Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 28, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 10, 2020 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 4, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 15, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 6, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Legacy Emanuel Medical Center
- FDA Inspection 1226424 - 2023-12-28
- FDA Inspection 1121919 - 2020-03-10
- FDA Inspection 1053026 - 2018-05-04
- FDA Inspection 857141 - 2013-11-15
- FDA Inspection 755865 - 2011-12-06
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