FDA Inspection
Fertility Unlimited Inc.Fertility Unlimited Inc. – FDA Inspection, Dec 28, 2011
Record Details
This FDA Inspection record concerns Fertility Unlimited Inc., with an inspection on December 28, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Fertility Unlimited Inc.
- Inspection Date
- December 28, 2011
- Product Type
- Biologics
View Company Profile
ID · 38f2d3d9-1868-4671-9b3e-f2c65827624f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 759778
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fertility Unlimited Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 2, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 11, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 4, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 4, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 11, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Fertility Unlimited Inc.
- FDA Inspection 1321382 - 2026-06-02
- FDA Inspection 1203012 - 2023-04-11
- FDA Inspection 1112668 - 2019-12-04
- FDA Inspection 1029232 - 2017-10-04
- FDA Inspection 952991 - 2015-12-11
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