FDA Inspection
Institute for Human Reproduction (IHR), SCInstitute for Human Reproduction (IHR), SC – FDA Inspection, May 10, 2012
Record Details
This FDA Inspection record concerns Institute for Human Reproduction (IHR), SC, with an inspection on May 10, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 10, 2012
- Product Type
- Biologics
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ID · 74b303ed-c8de-4c25-aefc-872df99f6613
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 759525
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
8- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.85(b)(1)Cell-associated CD
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
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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 |
| February 25, 2020 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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 |
Other documents for Institute for Human Reproduction (IHR), SC
- FDA Inspection 1314364 - 2026-04-22
- FDA Inspection 1221029 - 2023-10-25
- FDA Inspection 1118808 - 2020-02-25
- FDA Inspection 1095190 - 2019-06-13
- FDA Inspection 1014972 - 2017-06-07
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