FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, Aug 8, 2025
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on August 8, 2025, covering devices.
- Company
- Fresenius Kabi USA, LLC
- Inspection Date
- August 8, 2025
- Product Type
- Devices
View Company Profile
ID · e6910233-1465-45b7-bb8f-21b3c1123db8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1278050
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fresenius Kabi USA, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 7, 2023 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 18, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Fresenius Kabi USA, LLC
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.