FDA Inspection
Mount Sinai Hospital Blood BankMount Sinai Hospital Blood Bank – FDA Inspection, Nov 18, 2008
Record Details
This FDA Inspection record concerns Mount Sinai Hospital Blood Bank, with an inspection on November 18, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 18, 2008
- Product Type
- Biologics
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ID · e46de89a-47ff-4892-9c8d-ea1164094df2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 544732
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 820.75(a)Documentation - specific items
- 21 CFR 606.100(a)SOP compliance
- 21 CFR 630.40(b)(1)Deferred or not eligible
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 820.75(b)(2)Documentation of validated process performance
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Mount Sinai Hospital Blood Bank
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 2, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 13, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 24, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 19, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Mount Sinai Hospital Blood Bank
- FDA Inspection 1323324 - 2026-06-08
- FDA Inspection 1243297 - 2024-07-02
- FDA Inspection 1168200 - 2022-04-13
- FDA Inspection 1046035 - 2018-01-24
- FDA Inspection 950522 - 2015-11-19
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