FDA Inspection
Morristown Medical Center Blood BankMorristown Medical Center Blood Bank – FDA Inspection, Nov 8, 2011
Record Details
This FDA Inspection record concerns Morristown Medical Center Blood Bank, with an inspection on November 8, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 8, 2011
- Product Type
- Biologics
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ID · c92f3d3e-5d01-4a84-a7ca-ab3da0468877
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752925
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 640.21(a)Eligibility of platelet donors
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(c)Thorough investigations
- 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 |
|---|---|---|---|
| November 19, 2024 | VAI | New Jersey District Office | Blood and Blood Products |
| 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 |
Other documents for Morristown Medical Center Blood Bank
- FDA Inspection 1254505 - 2024-11-19
- FDA Inspection 1172619 - 2022-06-14
- FDA Inspection 1066704 - 2018-09-19
- FDA Inspection 936244 - 2015-07-14
- FDA Inspection 833690 - 2013-05-30
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