FDA Inspection
University of Michigan Center for Reproductive MedicineUniversity of Michigan Center for Reproductive Medicine – FDA Inspection, Mar 2, 2009
Record Details
This FDA Inspection record concerns University of Michigan Center for Reproductive Medicine, with an inspection on March 2, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 2, 2009
- Product Type
- Biologics
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ID · 64bcbea5-4ed2-424f-86bb-ed1cb76b2c8e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 568488
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
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Other FDA inspections of University of Michigan Center for Reproductive Medicine
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 2, 2025 | Not classified | Detroit District Office | |
| February 14, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 20, 2018 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 7, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 25, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for University of Michigan Center for Reproductive Medicine
- FDA Inspection 1272476 - 2025-06-02
- FDA Inspection 1084090 - 2019-02-14
- FDA Inspection 1044924 - 2018-03-20
- FDA Inspection 959777 - 2016-01-07
- FDA Inspection 841672 - 2013-07-25
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