Atlas

Form 483

Electromed, Inc. Form 483, 2026-02-12

FDA issued a Form 483 to Electromed, Inc. on 2026-02-12 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Electromed, Inc. · New Prague, United States · Issued February 12, 2026

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

12 Feb 2026
ISO 13485:2016 Clause 8.2.6

Monitoring and measurement requirements of product characteristics are not met

Cited by Christina L Bigham

12 Feb 2026
ISO 13485:2016 Clause 8.2.6

Monitoring and measurement requirements of product characteristics are not met

Cited by Christina L Bigham

12 Feb 2026
ISO 13485:2016 Clause 8.3.1

Procedure for nonconforming product not documented

Cited by Christina L Bigham

12 Feb 2026
ISO 13485:2016 Clause 8.3.1

Procedure for nonconforming product not documented

Cited by Christina L Bigham

Inspected site

EIElectromed, Inc.New Prague, United States

Inspection team

CLChristina L Bigham

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
ISO 13485:2016 Clause 8.2.6Cited across public-safe Form 483 observations2x
ISO 13485:2016 Clause 8.3.1Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere