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Form 483

Trophy SAS Form 483, 2023-03-10

FDA issued a Form 483 to Trophy SAS on 2023-03-10 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Trophy SAS · Marne La Vallee Cedex 2, France · Issued March 10, 2023

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.

10 Mar 2023
21 CFR 1003.10(a)

FDA not notified of defect or noncompliance

Cited by Andrew J Garufi

Inspected site

TSTrophy SASMarne La Vallee Cedex 2, France

Inspection team

AJAndrew J Garufi

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1003.10(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