FDA Inspection
Illume FertilityIllume Fertility – FDA Inspection, Apr 6, 2016
Record Details
This FDA Inspection record concerns Illume Fertility, with an inspection on April 6, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Illume Fertility
- Inspection Date
- April 6, 2016
- Product Type
- Biologics
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ID · a9db7c60-8357-49f1-89c1-72c069f07ad3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 964581
- 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 1271.47(a)Procedures for all other requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Illume Fertility
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2026 | Not classified | New England District Office | Human Cellular, Tissue, and Gene Therapies |
| June 30, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 23, 2021 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 3, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 13, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Illume Fertility
- FDA Inspection 1316476 - 2026-05-08
- FDA Inspection 1209647 - 2023-06-30
- FDA Inspection 1136119 - 2021-02-23
- FDA Inspection 1049283 - 2018-04-03
- FDA Inspection 859492 - 2013-12-13
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