FDA Inspection
Columbia University Fertility CenterColumbia University Fertility Center – FDA Inspection, Sep 25, 2018
Record Details
This FDA Inspection record concerns Columbia University Fertility Center, with an inspection on September 25, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · f2697bbe-19a7-4d86-9e47-46f60938da80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066635
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.50(a)Responsible person to determine, document
Full citation text and observation details available on the Dashboard.
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 |
| July 8, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 28, 2014 | 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 978264 - 2016-07-08
- FDA Inspection 894377 - 2014-08-28
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.