FDA Inspection
Ion Medical, Inc.Ion Medical, Inc. – FDA Inspection, Jun 13, 2025
Record Details
This FDA Inspection record concerns Ion Medical, Inc., with an inspection on June 13, 2025, issued by the Florida District Office, covering medical devices & rad health.
View Company Profile
ID · 824f56e8-344a-47fb-8f5d-b88f2026786f
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1272617
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.40(a)Document review, approval documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ion Medical, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 22, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 15, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 22, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ion Medical, Inc.
- FDA Inspection 1276194 - 2025-07-16
- FDA Inspection 1050613 - 2018-03-22
- FDA Inspection 895077 - 2014-09-15
- FDA Inspection 746941 - 2011-09-22
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.