Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-06.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Mar 2026 – 6 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Aug 2025 – 21 Aug 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Nov 2022 – 17 Nov 2022 | Medical Devices & Rad Health | Clean | |
| 19 Nov 2019 – 26 Nov 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jun 2016 – 16 Jun 2016 | Medical Devices & Rad Health | Clean | |
| 24 Sep 2013 – 25 Sep 2013 | Medical Devices & Rad Health | Clean | |
| 7 Feb 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Apr 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Christopher B May, Lashawn M Elam
6 Apr 2026
ISO 13485:2016 Clause 8.5.2
Corrective actions were unduly delayed
Cited by Christopher B May, Lashawn M Elam
Investigators
FDA investigators tied to this site in the record.
Lashawn M Elam2 insp.
Christopher B May1 insp.
Inga M Warr1 insp.
David E Lowe1 insp.
Samuel L Murray1 insp.
Ernest H Blackwood1 insp.
Perry H Gambrell1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.1 | 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 Robling Medical LLC's 3 Form 483s
Source PDFs and 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