FDA Inspection
North Shore University Hospital Northwell HealthNorth Shore University Hospital Northwell Health – FDA Inspection, Feb 23, 2016
Record Details
This FDA Inspection record concerns North Shore University Hospital Northwell Health, with an inspection on February 23, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 23, 2016
- Product Type
- Biologics
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ID · b7c8580a-99ce-42b3-9a2f-6cc39815c1a5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 960774
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.75(c)Reproductive cells/ tissues- general
- 21 CFR 1271.47(a)Procedures for all other requirements
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Other FDA inspections of North Shore University Hospital Northwell Health
16| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2026 | Not classified | New York District Office | Blood and Blood Products |
| March 4, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 12, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 26, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 20, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
Other documents for North Shore University Hospital Northwell Health
- FDA Inspection 1306816 - 2026-03-11
- FDA Inspection 1307150 - 2026-03-04
- FDA Inspection 1241373 - 2024-06-12
- FDA Inspection 1203742 - 2023-04-26
- FDA Inspection 1174916 - 2022-07-20
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