FDA Inspection
North Shore University Hospital Northwell HealthNorth Shore University Hospital Northwell Health – FDA Inspection, Mar 11, 2026
Record Details
This FDA Inspection record concerns North Shore University Hospital Northwell Health, with an inspection on March 11, 2026, issued by the New York District Office, covering biologics.
- Inspection Date
- March 11, 2026
- Product Type
- Biologics
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ID · 1714ef33-f270-4630-ab1e-a50de193f782
Inspection Facts
- Inspection number
- 1306816
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 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 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 |
| 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 1307150 - 2026-03-04
- FDA Inspection 1241373 - 2024-06-12
- FDA Inspection 1203742 - 2023-04-26
- FDA Inspection 1174916 - 2022-07-20
- FDA Inspection 1120549 - 2020-03-12
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