FDA Inspection
University of Michigan Center for Reproductive MedicineUniversity of Michigan Center for Reproductive Medicine – FDA Inspection, Mar 20, 2018
Record Details
This FDA Inspection record concerns University of Michigan Center for Reproductive Medicine, with an inspection on March 20, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 20, 2018
- Product Type
- Biologics
View Company Profile
ID · 85f80c28-7587-4130-9d57-3045e27984c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044924
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
| June 22, 2011 | NAI | 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 959777 - 2016-01-07
- FDA Inspection 841672 - 2013-07-25
- FDA Inspection 731053 - 2011-06-22
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.