FDA Inspection
Stony Brook University Medical CenterStony Brook University Medical Center – FDA Inspection, Sep 30, 2014
Record Details
This FDA Inspection record concerns Stony Brook University Medical Center, with an inspection on September 30, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 30, 2014
- Product Type
- Biologics
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ID · acaa7030-2eab-4ef1-ba17-d2c189ab9244
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 897972
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 640.25(a)Storage temps./agitation
- 21 CFR 606.160(a)(1)Concurrent documentation
- 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 |
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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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