Atlas

Form 483

Aesthetic Group Form 483, 2023-03-23

FDA issued a Form 483 to Aesthetic Group on 2023-03-23 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Aesthetic Group · Puiseux Le Hauberger, France · Issued March 23, 2023

Overview

  • 2 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.

23 Mar 2023
21 CFR 820.50(a)(1)

Documented evaluation

Cited by Melissa A Zuppe

23 Mar 2023
21 CFR 820.90(a)

Nonconforming product control

Cited by Melissa A Zuppe

Inspected site

AGAesthetic GroupPuiseux Le Hauberger, France

Inspection team

MAMelissa A Zuppe

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.50(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.90(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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