FDA Inspection
Stony Brook University Medical CenterStony Brook University Medical Center – FDA Inspection, Feb 7, 2023
Record Details
This FDA Inspection record concerns Stony Brook University Medical Center, with an inspection on February 7, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · ff19102a-1df6-4a1a-95eb-d987f3201e75
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196757
- 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(b)Required records
- 21 CFR 606.171Biological product deviation report
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Other FDA inspections of Stony Brook University Medical Center
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 27, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 7, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 14, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 18, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 30, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Stony Brook University Medical Center
- FDA Inspection 1271190 - 2025-05-27
- FDA Inspection 1232197 - 2024-03-07
- FDA Inspection 1082588 - 2019-03-14
- FDA Inspection 988207 - 2016-10-18
- FDA Inspection 897972 - 2014-09-30
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