FDA Inspection
North Shore University Hospital Northwell HealthNorth Shore University Hospital Northwell Health – FDA Inspection, Mar 23, 2011
Record Details
This FDA Inspection record concerns North Shore University Hospital Northwell Health, with an inspection on March 23, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 23, 2011
- Product Type
- Biologics
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ID · 2fd34dc3-d76f-4942-8b9c-1477c71d5a8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 715912
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 606.160(b)Required records
- 21 CFR 640.11(a)General requirements - storage
- 21 CFR 640.25(a)Storage temps./agitation
- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 640.4(f)Arm preparation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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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