Atlas

Form 483

Manatec S.A.R.L. Form 483, 2023-02-09

FDA issued a Form 483 to Manatec S.A.R.L. on 2023-02-09 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Manatec S.A.R.L. · Poissy, France · Issued February 9, 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.

9 Feb 2023
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Natasha R Johnson

Inspected site

MSManatec S.A.R.L.Poissy, France

Inspection team

NRNatasha R Johnson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.50Cited 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