FDA Inspection
Illume FertilityIllume Fertility – FDA Inspection, May 8, 2026
Record Details
This FDA Inspection record concerns Illume Fertility, with an inspection on May 8, 2026, issued by the New England District Office, covering biologics.
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ID · 6d5e828d-7b06-46c1-9302-21ef76feb3eb
Inspection Facts
- Inspection number
- 1316476
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.55(c)Name and personal info on accompanying records
- 21 CFR 1271.90(c)Eligibility not required--warning labels
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Other FDA inspections of Illume Fertility
7| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| April 6, 2016 | VAI | 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 1209647 - 2023-06-30
- FDA Inspection 1136119 - 2021-02-23
- FDA Inspection 1049283 - 2018-04-03
- FDA Inspection 964581 - 2016-04-06
- FDA Inspection 859492 - 2013-12-13
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