Form 483

Guinot Form 483, 2024-04-26

FDA issued a Form 483 to Guinot on 2024-04-26 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Guinot · Dammarie-Les-Lys, France · Issued April 26, 2024

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.

26 Apr 2024
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Juanita P Versace

Inspected site

GGuinotDammarie-Les-Lys, France

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(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