FDA Inspection
CXMedUS, Inc.FDA Inspection 1201923 - CXMedUS, Inc. - April 06, 2023
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.
Record Details
This FDA Inspection record concerns CXMedUS, Inc., with an inspection on April 6, 2023, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 9c056525-e894-445b-b83b-e9cde5ded981
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1201923
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
Full citation text and observation details available on the Dashboard.