FDA Inspection
Montefiore Medical Center Blood BankMontefiore Medical Center Blood Bank – FDA Inspection, Apr 29, 2025
Record Details
This FDA Inspection record concerns Montefiore Medical Center Blood Bank, with an inspection on April 29, 2025, issued by the New York District Office, covering biologics.
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ID · 86b43e3d-851a-478b-af40-cd589b272ec4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1268343
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.160(b)Required records
- 21 CFR 600.12(a)Maintenance - tracing
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Montefiore Medical Center Blood Bank
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 25, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 9, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 20, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 18, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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