FDA Inspection
Loyola Univ Medical CenterLoyola Univ Medical Center – FDA Inspection, Dec 5, 2024
Record Details
This FDA Inspection record concerns Loyola Univ Medical Center, with an inspection on December 5, 2024, issued by the Chicago District Office, covering biologics.
View Company Profile
ID · d081d0f8-e961-41f0-bc54-254cad1ac96a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1255837
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 600.12(a)Maintenance - concurrence
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Loyola Univ Medical Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 20, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 23, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 5, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 3, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Loyola Univ Medical Center
- FDA Inspection 1281146 - 2025-09-08
- FDA Inspection 1106929 - 2019-09-20
- FDA Inspection 1008776 - 2017-03-23
- FDA Inspection 913470 - 2015-02-05
- FDA Inspection 831806 - 2013-05-03
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.