FDA Inspection
Fertility Center LLCFertility Center LLC – FDA Inspection, Sep 18, 2024
Record Details
This FDA Inspection record concerns Fertility Center LLC, with an inspection on September 18, 2024, issued by the New Orleans District Office, covering biologics.
View Company Profile
ID · 716a73e7-d3c6-48d1-ac2a-6ca850f1ca0b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249470
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.90(c)Eligibility not required--warning labels
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fertility Center LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 3, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 5, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Fertility Center LLC
- FDA Inspection 1053797 - 2018-02-12
- FDA Inspection 950470 - 2015-12-03
- FDA Inspection 857815 - 2013-12-05
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.