Form 483

Max Mobility LLC Form 483, 2026-04-16

FDA issued a Form 483 to Max Mobility LLC on 2026-04-16 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Max Mobility LLC · Lebanon, United States · Issued April 16, 2026

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.

16 Apr 2026
ISO 13485:2016 Clause 7.3.9

Procedures to control design and development changes not documented

Cited by Jamie P Webb

Inspected site

MMMax Mobility LLCLebanon, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
ISO 13485:2016 Clause 7.3.9Cited across public-safe Form 483 observations1x

Full 483 report

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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