FDA Inspection
Montefiore Medical Center Blood BankMontefiore Medical Center Blood Bank – FDA Inspection, May 18, 2023
Record Details
This FDA Inspection record concerns Montefiore Medical Center Blood Bank, with an inspection on May 18, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · a6941762-25e5-4b61-b0fa-f7e9798fe212
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1205526
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.20(b)Qualifications of responsible personnel
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Other FDA inspections of Montefiore Medical Center Blood Bank
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2025 | VAI | New York District Office | 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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