FDA Inspection
Carolinas Fertility InstituteCarolinas Fertility Institute – FDA Inspection, May 19, 2016
Record Details
This FDA Inspection record concerns Carolinas Fertility Institute, with an inspection on May 19, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 19, 2016
- Product Type
- Biologics
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ID · 72936dfb-f231-4421-a3e4-2930ea6e99ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 970575
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.65(a)Improper release prevention--storage, I.D.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Carolinas Fertility Institute
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2025 | Not classified | Atlanta District Office | |
| July 27, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 26, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 14, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Carolinas Fertility Institute
- FDA Inspection 1269744 - 2025-05-02
- FDA Inspection 1211469 - 2023-07-27
- FDA Inspection 1121329 - 2020-02-26
- FDA Inspection 1043604 - 2018-02-14
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