FDA Inspection
North Shore University Hospital Northwell HealthNorth Shore University Hospital Northwell Health – FDA Inspection, Apr 26, 2023
Record Details
This FDA Inspection record concerns North Shore University Hospital Northwell Health, with an inspection on April 26, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 26, 2023
- Product Type
- Biologics
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ID · 89b9fdb0-af90-46c5-b417-dd0323d2d0d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1203742
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 606.160(b)Required records
- 21 CFR 600.14(a)(1)Who must report - manufacturer
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 600.14(a)(1)Who must report - manufacturer
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.160(b)Required records
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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 |
| July 20, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| March 12, 2020 | 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 1174916 - 2022-07-20
- FDA Inspection 1120549 - 2020-03-12
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