Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-13.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Feb 2026 – 13 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Mar 2015 – 25 Mar 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Aug 2012 | Not recorded | 483 | View 483 → |
| 21 Jul 2010 | Not recorded | 483 | On file |
| 6 Aug 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Feb 2026
ISO 13485:2016 Clause 7.3.7
Design and development validation not complete prior to release of product
Cited by Marvin A Marenco
17 Aug 2012
21 CFR 820.22
Quality audits - auditor independence
Cited by Phillip M Pontikos, Darla R Bracy, Randall F Albright
17 Aug 2012
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Phillip M Pontikos, Darla R Bracy, Randall F Albright
Investigators
FDA investigators tied to this site in the record.
Marvin A Marenco1 insp.
James D Hildreth1 insp.
Phillip M Pontikos1 insp.
Darla R Bracy1 insp.
Randall F Albright1 insp.
Jeffrey W Shrifter1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.7 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind NDS Surgical Imaging LLC's 4 Form 483s
Source PDFs, verbatim observations, 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