FDA Inspection
Stony Brook University Medical CenterStony Brook University Medical Center – FDA Inspection, Jul 18, 2012
Record Details
This FDA Inspection record concerns Stony Brook University Medical Center, with an inspection on July 18, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 18, 2012
- Product Type
- Biologics
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ID · 79e13675-27a0-43b6-8f62-074249d72e20
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 791259
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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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 |
| February 7, 2023 | 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 |
Other documents for Stony Brook University Medical Center
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- FDA Inspection 1196757 - 2023-02-07
- FDA Inspection 1082588 - 2019-03-14
- FDA Inspection 988207 - 2016-10-18
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