FDA Inspection
Reproductive Care CenterReproductive Care Center – FDA Inspection, May 14, 2025
Record Details
This FDA Inspection record concerns Reproductive Care Center, with an inspection on May 14, 2025, issued by the Denver District Office, covering biologics.
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ID · b7a8667c-6745-4472-bc44-192214f4d263
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1269605
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.50(a)Determination based on screening and testing
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Reproductive Care Center
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2022 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 15, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 5, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 7, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Reproductive Care Center
- FDA Inspection 1162086 - 2022-02-11
- FDA Inspection 1001142 - 2017-02-15
- FDA Inspection 823141 - 2013-03-05
- FDA Inspection 662392 - 2010-05-07
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