FDA Inspection
Montefiore Medical Center Blood BankMontefiore Medical Center Blood Bank – FDA Inspection, Dec 22, 2009
Record Details
This FDA Inspection record concerns Montefiore Medical Center Blood Bank, with an inspection on December 22, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 22, 2009
- Product Type
- Biologics
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ID · 45808fb0-ea22-4a3f-9ed0-32dede850500
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 632637
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 630.40(a)Notification
- 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 |
|---|---|---|---|
| April 29, 2025 | VAI | New York District Office | Blood and Blood Products |
| 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 |
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