Burton Medical

Form 483 issued February 20, 2026 · Addison, Illinois

Inspection
Feb 17 – Feb 20, 2026
Investigator
Hammam A. Abdallah
Observations
1
Pages
3
FEI number
3009542956

In short: On February 20, 2026, FDA issued a Form 483 with 1 observation to Burton Medical in Addison, Illinois (FEI 3009542956) after an inspection that ran Feb 17 – Feb 20, 2026. The investigator was Hammam A. Abdallah. The most-cited regulation is 21 CFR 830.300 (devices subject to device identification data submission requirements).

What FDA observed

Preview: the opening words of each observation
  1. 01

    The information required by the Global Unique Device Identification Database for each medical device version or…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at Burton Medical?

FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 830.300 (devices subject to device identification data submission requirements). The opening words of each observation are shown on this page.

Who inspected Burton Medical?

Hammam A. Abdallah is named on this Form 483, for the inspection of Feb 17 – Feb 20, 2026. Each investigator has a profile showing what they cite most.

When was Burton Medical inspected by FDA?

The inspection ran Feb 17 – Feb 20, 2026, and the Form 483 is dated February 20, 2026.

How do I get the full Form 483 for Burton Medical?

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