Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-06.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2026 – 6 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Dec 2017 – 6 Dec 2017 | Medical Devices & Rad Health | Clean | |
| 19 Jun 2015 – 17 Jul 2015 | Medical Devices & Rad Health | Clean | |
| 16 May 2014 – 28 May 2014 | Medical Devices & Rad Health | 483 | On file |
| 27 Aug 2013 – 24 Sep 2013 | Medical Devices & Rad Health | WL | View 483 → |
| 12 May 2010 | Not recorded | 483 | On file |
| 10 Feb 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Feb 2026
ISO 13485:2016 Clause 8.3.1
Nonconforming product not adequately evaluated
Cited by Chad E Schmear
6 Feb 2026
ISO 13485:2016 Clause 8.3.1
Nonconforming product not identified and controlled
Cited by Chad E Schmear
24 Sep 2013
21 CFR 820.70(g)(1)
Maintenance schedule, Lack of or inadequate schedule
Cited by Nicole S Williams
24 Sep 2013
21 CFR 820.70(g)(2)
Periodic equipment inspection lack of or inadequate procedu
Cited by Nicole S Williams
24 Sep 2013
21 CFR 820.75(c)
Process changes - review, evaluation and revalidation
Cited by Nicole S Williams
Investigators
FDA investigators tied to this site in the record.
That Q Dang2 insp.
Patricia A Mcilroy2 insp.
Chad E Schmear1 insp.
Todd Q Dang1 insp.
Nicole S Williams1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 8.3.1 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medline Industries, LP'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