Form 483

Michael Todd Beauty LP Form 483, 2026-05-20

FDA issued a Form 483 to Michael Todd Beauty LP on 2026-05-20 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Michael Todd Beauty LP · Port St Lucie, United States · Issued May 20, 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.

20 May 2026
21 CFR 801.20(a)

Label to bear a unique device identifier

Cited by Alex J Wild

20 May 2026
21 CFR 801.20(a)

Label to bear a unique device identifier

Cited by Alex J Wild

20 May 2026
ISO 13485:2016 Clause 8.2.4

Internal audit procedures not documented

Cited by Alex J Wild

20 May 2026
ISO 13485:2016 Clause 8.2.4

Internal audit procedures not documented

Cited by Alex J Wild

Inspected site

MTMichael Todd Beauty LPPort St Lucie, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 801.20(a)Cited across public-safe Form 483 observations2x
ISO 13485:2016 Clause 8.2.4Cited 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