Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-24.
At a glance
Inspections
9
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Apr 2026 – 24 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 May 2023 – 8 Jun 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Dec 2019 – 19 Dec 2019 | Medical Devices & Rad Health | Clean | |
| 7 Apr 2017 – 20 Apr 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Oct 2014 – 28 Oct 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Aug 2011 | Not recorded | Clean | |
| 1 May 2006 | Not recorded | Clean | |
| 2 Apr 2002 | Not recorded | Clean | |
| 23 Oct 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Apr 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Monica L Gutierrez, Jaro P Perera
24 Apr 2026
ISO 13485:2016 Clause 8.3.1
Procedure for nonconforming product not documented
Cited by Monica L Gutierrez, Jaro P Perera
8 Jun 2023
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Frank J Marciniak, Melissa A Zuppe, Naakesh N Gomanie
Investigators
FDA investigators tied to this site in the record.
Monica L Gutierrez1 insp.
Jaro P Perera1 insp.
Frank J Marciniak1 insp.
Melissa A Zuppe1 insp.
Naakesh N Gomanie1 insp.
William R Chang1 insp.
Esteban Beltran1 insp.
Gobiga Vanniyasingam1 insp.
Li Li1 insp.
Richard L Rutherford1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g) | 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 8.3.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lynx Medical of NJ 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