FDA Inspection
Organ Procurement Agency of MichiganOrgan Procurement Agency of Michigan – FDA Inspection, Apr 23, 2009
Record Details
This FDA Inspection record concerns Organ Procurement Agency of Michigan, with an inspection on April 23, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 23, 2009
- Product Type
- Biologics
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ID · 3a5850db-e112-4f78-9ebc-76d98dd538d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 579781
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.47(d)Departures: recording and justifying
- 21 CFR 1271.270(a)Accurate, indelible, legible
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Organ Procurement Agency of Michigan
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2025 | Not classified | Detroit District Office | Human Cellular, Tissue, and Gene Therapies |
| September 14, 2021 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 23, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 22, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 1, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Organ Procurement Agency of Michigan
- FDA Inspection 1273030 - 2025-06-18
- FDA Inspection 1154387 - 2021-09-14
- FDA Inspection 1111270 - 2019-10-23
- FDA Inspection 1028519 - 2017-09-22
- FDA Inspection 920737 - 2015-04-01
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