FDA Inspection
Freudenberg Medical, LlcFreudenberg Medical, Llc – FDA Inspection, May 15, 2026
Record Details
This FDA Inspection record concerns Freudenberg Medical, Llc, with an inspection on May 15, 2026, issued by the Detroit District Office, covering medical devices & rad health.
View Company Profile
ID · e62dd8ac-f821-4289-958d-72cea89ceac5
Inspection Facts
- Inspection number
- 1319114
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 7.4.3Purchased product verification activities are inadequate
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.4Procedures for data analysis do not include determination of appropriate methods
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Freudenberg Medical, Llc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2025 | Not classified | Detroit District Office | |
| July 22, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 21, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 18, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Freudenberg Medical, Llc
- FDA Inspection 1259843 - 2025-01-17
- FDA Inspection 936462 - 2015-07-22
- FDA Inspection 837157 - 2013-06-21
- FDA Inspection 759057 - 2011-11-18
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.