FDA Inspection
ART Fertility Program of AlabamaART Fertility Program of Alabama – FDA Inspection, Jun 5, 2018
Record Details
This FDA Inspection record concerns ART Fertility Program of Alabama, with an inspection on June 5, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 83fdb54b-1aa4-45dd-9e1f-90eb3a99d0f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055373
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1271.75(d)Donors with risks not determined ineligible
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Other FDA inspections of ART Fertility Program of Alabama
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 15, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 16, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 9, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for ART Fertility Program of Alabama
- FDA Inspection 1123174 - 2020-01-28
- FDA Inspection 961629 - 2016-01-15
- FDA Inspection 876575 - 2014-04-16
- FDA Inspection 771795 - 2012-03-09
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