FDA Inspection
Mount Sinai Hospital Blood BankMount Sinai Hospital Blood Bank – FDA Inspection, Jul 2, 2024
Record Details
This FDA Inspection record concerns Mount Sinai Hospital Blood Bank, with an inspection on July 2, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · eab97864-0a8d-4393-8ecc-64033c7007ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1243297
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.160(b)Required records
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| 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 |
| July 28, 2014 | 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 1168200 - 2022-04-13
- FDA Inspection 1046035 - 2018-01-24
- FDA Inspection 950522 - 2015-11-19
- FDA Inspection 889365 - 2014-07-28
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