Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-05-15.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 May 2026 – 15 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Jan 2025 – 17 Jan 2025 | Medical Devices & Rad Health | Clean | |
| 20 Jul 2015 – 22 Jul 2015 | Medical Devices & Rad Health | Clean | |
| 18 Jun 2013 – 21 Jun 2013 | Medical Devices & Rad Health | Clean | |
| 18 Nov 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 May 2026
ISO 13485:2016 Clause 7.4.3
Purchased product verification activities are inadequate
Cited by Suyang Qin
15 May 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling procedures not documented
Cited by Suyang Qin
15 May 2026
ISO 13485:2016 Clause 8.4
Procedures for data analysis do not include determination of appropriate methods
Cited by Suyang Qin
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.4.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Freudenberg Medical, LLC's 1 Form 483
Recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat