FDA Inspection
NYU Langone Health HospitalNYU Langone Health Hospital – FDA Inspection, Dec 19, 2008
Record Details
This FDA Inspection record concerns NYU Langone Health Hospital, with an inspection on December 19, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- NYU Langone Health Hospital
- Inspection Date
- December 19, 2008
- Product Type
- Biologics
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ID · 8b727fa1-5703-401e-bc3b-9b91a1f49a42
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 550884
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of NYU Langone Health Hospital
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 26, 2024 | VAI | New York District Office | Blood and Blood Products |
| August 19, 2022 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 18, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 9, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for NYU Langone Health Hospital
- FDA Inspection 1274509 - 2025-06-27
- FDA Inspection 1250142 - 2024-09-26
- FDA Inspection 1177868 - 2022-08-19
- FDA Inspection 1015463 - 2017-05-18
- FDA Inspection 922842 - 2015-04-09
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