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Form 483

Edermy LLC Form 483, 2025-12-23

FDA issued a Form 483 to Edermy LLC on 2025-12-23 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Edermy LLC · Pendergrass, United States · Issued December 23, 2025

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

23 Dec 2025
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Dawn M Braswell

Inspected site

ELEdermy LLCPendergrass, United States

Inspection team

DMDawn M Braswell

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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