FDA Inspection
Institute for Human Reproduction (IHR), SCInstitute for Human Reproduction (IHR), SC – FDA Inspection, Feb 25, 2020
Record Details
This FDA Inspection record concerns Institute for Human Reproduction (IHR), SC, with an inspection on February 25, 2020, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 25, 2020
- Product Type
- Biologics
View Company Profile
ID · a23023c1-a586-4861-a705-23887c2dbba6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1118808
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Institute for Human Reproduction (IHR), SC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 25, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 13, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 7, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 8, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Institute for Human Reproduction (IHR), SC
- FDA Inspection 1314364 - 2026-04-22
- FDA Inspection 1221029 - 2023-10-25
- FDA Inspection 1095190 - 2019-06-13
- FDA Inspection 1014972 - 2017-06-07
- FDA Inspection 978097 - 2016-07-08
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.