FDA Inspection
Mount Sinai Hospital Blood BankMount Sinai Hospital Blood Bank – FDA Inspection, Aug 17, 2010
Record Details
This FDA Inspection record concerns Mount Sinai Hospital Blood Bank, with an inspection on August 17, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 17, 2010
- Product Type
- Biologics
View Company Profile
ID · 3287af02-ed95-4d7e-9092-8d3d1105b43b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 675139
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 640.4(h)Storage temperatures after collection
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.171Biological product deviation report
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 606.100(b)(21)Donor notification
- 21 CFR 606.100(b)(2)Donor qualifying tests & measurements
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
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.