FDA Inspection
The Centre for Reproductive MedicineThe Centre for Reproductive Medicine – FDA Inspection, Jun 21, 2013
Record Details
This FDA Inspection record concerns The Centre for Reproductive Medicine, with an inspection on June 21, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 21, 2013
- Product Type
- Biologics
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ID · 32b122c6-47dd-4753-8ba9-63339906b5cc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 837597
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.85(c)Reproductive cells or tissues
- 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 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
Full citation text and observation details available on the Dashboard.
Other FDA inspections of The Centre for Reproductive Medicine
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 1, 2025 | Not classified | Dallas District Office | |
| July 15, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 18, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 13, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 15, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for The Centre for Reproductive Medicine
- FDA Inspection 1266223 - 2025-04-01
- FDA Inspection 1098671 - 2019-07-15
- FDA Inspection 963378 - 2016-02-18
- FDA Inspection 865603 - 2014-02-13
- FDA Inspection 724866 - 2011-04-15
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