Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-11.
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 |
|---|---|---|---|
| 9 Mar 2026 – 11 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Mar 2022 – 25 Mar 2022 | Human Drugs | 483 | View 483 → |
| 9 Aug 2018 – 17 Aug 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Apr 2015 – 24 Apr 2015 | Medical Devices & Rad Health | Clean | |
| 11 Sep 2013 – 12 Sep 2013 | Medical Devices & Rad Health | Clean | |
| 7 Mar 2011 | Not recorded | Clean | |
| 23 Apr 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Mar 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Matthew D Schnittker
11 Mar 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Matthew D Schnittker
25 Mar 2022
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Sony Mathews, Syeda N Mahazabin, Juliana M Badalucco
25 Mar 2022
21 CFR 211.192
Written record of investigation incomplete
Cited by Sony Mathews, Syeda N Mahazabin, Juliana M Badalucco
25 Mar 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Sony Mathews, Syeda N Mahazabin, Juliana M Badalucco
Investigators
FDA investigators tied to this site in the record.
Katelyn A Staub-Zamperini2 insp.
James M Odonnell2 insp.
Matthew D Schnittker1 insp.
Sony Mathews1 insp.
Syeda N Mahazabin1 insp.
Juliana M Badalucco1 insp.
Gladys B Casper1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lynx Medical Pennsylvania's 3 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