FDA Inspection
New York Presbyterian Hospital-Columbia University Med. Ctr.New York Presbyterian Hospital-Columbia University Med. Ctr. – FDA Inspection, Nov 28, 2023
Record Details
This FDA Inspection record concerns New York Presbyterian Hospital-Columbia University Med. Ctr., with an inspection on November 28, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 28, 2023
- Product Type
- Biologics
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ID · 553ef8a6-8049-4b1b-8ea1-255f40c71415
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1223803
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 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
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(b)Required records
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
Full citation text and observation details available on the Dashboard.
Other FDA inspections of New York Presbyterian Hospital-Columbia University Med. Ctr.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 10, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 6, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 2, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 29, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for New York Presbyterian Hospital-Columbia University Med. Ctr.
- FDA Inspection 1325654 - 2026-07-02
- FDA Inspection 1086853 - 2019-04-10
- FDA Inspection 1006752 - 2017-04-06
- FDA Inspection 905645 - 2014-12-02
- FDA Inspection 816284 - 2013-01-29
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