FDA Inspection
Morristown Medical Center Blood BankMorristown Medical Center Blood Bank – FDA Inspection, Nov 19, 2024
Record Details
This FDA Inspection record concerns Morristown Medical Center Blood Bank, with an inspection on November 19, 2024, issued by the New Jersey District Office, covering biologics.
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ID · 1a448ec1-b655-4b9b-b8bf-2ce6047237c9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1254505
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Morristown Medical Center Blood Bank
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 19, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 14, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 30, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 8, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Morristown Medical Center Blood Bank
- FDA Inspection 1172619 - 2022-06-14
- FDA Inspection 1066704 - 2018-09-19
- FDA Inspection 936244 - 2015-07-14
- FDA Inspection 833690 - 2013-05-30
- FDA Inspection 752925 - 2011-11-08
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