Medline Industries - Arlington Heights
Form 483 issued February 6, 2026 · Illinois
- Inspection
- Feb 3 – Feb 6, 2026
- Investigator
- Chad E. Schmear
- Observations
- 2
- Pages
- 4
- FEI number
- 1417411
In short: On February 6, 2026, FDA issued a Form 483 with 2 observations to Medline Industries - Arlington Heights in Illinois (FEI 1417411) after an inspection that ran Feb 3 – Feb 6, 2026. The investigator was Chad E. Schmear. The most-cited regulation is 21 CFR 8.3.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 8.3.1
Product which does not conform to product requirements was not adequately identified and controlled to prevent…
- 02ISO 13485:2016 Clause 8.3.1
Nonconforming product was not adequately evaluated to determine the need for an investigation and notification of…
This inspection in context
Chad E. Schmear
4 documents · 2002–2026
Cites ISO 13485:2016 Clause 8.3.1 more than any other section. Most of their documents are for sites in Wisconsin.
The firmMedline Industries - Arlington Heights history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Medline Industries - Arlington Heights?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 8.3. The opening words of each observation are shown on this page.
Who inspected Medline Industries - Arlington Heights?
Chad E. Schmear is named on this Form 483, for the inspection of Feb 3 – Feb 6, 2026. Each investigator has a profile showing what they cite most.
When was Medline Industries - Arlington Heights inspected by FDA?
The inspection ran Feb 3 – Feb 6, 2026, and the Form 483 is dated February 6, 2026.
How do I get the full Form 483 for Medline Industries - Arlington Heights?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.