FDA Inspection
Stony Brook Community Medical PC - Island FertilityStony Brook Community Medical PC - Island Fertility – FDA Inspection, May 28, 2024
Record Details
This FDA Inspection record concerns Stony Brook Community Medical PC - Island Fertility, with an inspection on May 28, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 28, 2024
- Product Type
- Biologics
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ID · 82b37746-092d-408f-bb65-5d5bea9c59b7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1239667
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.50(b)(2)Donor testing not negative for CD agents
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of Stony Brook Community Medical PC - Island Fertility
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 13, 2022 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 30, 2021 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Stony Brook Community Medical PC - Island Fertility
- FDA Inspection 1174352 - 2022-07-13
- FDA Inspection 1147466 - 2021-07-30
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