FDA Inspection
Northwell Health LaboratoriesNorthwell Health Laboratories – FDA Inspection, Mar 28, 2011
Record Details
This FDA Inspection record concerns Northwell Health Laboratories, with an inspection on March 28, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 28, 2011
- Product Type
- Biologics
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ID · 330e320c-7a77-4bef-a4c5-b7cce8084ebf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 713752
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.230(a)Process validation procedures
- 21 CFR 1271.270(a)Records incomplete
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Other FDA inspections of Northwell Health Laboratories
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 6, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 9, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Northwell Health Laboratories
- FDA Inspection 1335594 - 2026-09-08
- FDA Inspection 1166884 - 2022-04-06
- FDA Inspection 1075287 - 2018-11-09
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