FDA Inspection
Reproductive Medicine Associates of Michigan, PLCReproductive Medicine Associates of Michigan, PLC – FDA Inspection, Jul 27, 2009
Record Details
This FDA Inspection record concerns Reproductive Medicine Associates of Michigan, PLC, with an inspection on July 27, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 27, 2009
- Product Type
- Biologics
View Company Profile
ID · 5954399b-10e3-4cd5-9257-7e4845988b7d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 599704
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
- 21 CFR 1271.50(b)(2)Donor testing not negative for CD agents
- 21 CFR 1271.60(a)Completion of eligibility determination
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of Reproductive Medicine Associates of Michigan, PLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 6, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 31, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 30, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 20, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Reproductive Medicine Associates of Michigan, PLC
- FDA Inspection 1195188 - 2023-01-17
- FDA Inspection 1057819 - 2018-06-06
- FDA Inspection 974547 - 2016-05-31
- FDA Inspection 847777 - 2013-08-30
- FDA Inspection 678161 - 2010-08-20
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