FDA Inspection
Columbia University Fertility CenterColumbia University Fertility Center – FDA Inspection, Sep 17, 2009
Record Details
This FDA Inspection record concerns Columbia University Fertility Center, with an inspection on September 17, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 17, 2009
- Product Type
- Biologics
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ID · 087d4f5d-a6c6-44da-9761-4a5efb63efdf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 612559
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.75(e)Abbreviated procedure
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of Columbia University Fertility Center
7| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2024 | VAI | New York District Office | Human Cellular, Tissue, and Gene Therapies |
| November 28, 2022 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 23, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 25, 2018 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 8, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Columbia University Fertility Center
- FDA Inspection 1257162 - 2024-12-20
- FDA Inspection 1191445 - 2022-11-28
- FDA Inspection 1097178 - 2019-07-23
- FDA Inspection 1066635 - 2018-09-25
- FDA Inspection 978264 - 2016-07-08
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