Atlas

Form 483

Vipamat SAS Form 483, 2017-11-16

FDA issued a Form 483 to Vipamat SAS on 2017-11-16 with 8 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health8 observations

Vipamat SAS · Ploemeur, France · Issued November 16, 2017

Overview

  • 8 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.

16 Nov 2017
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Stephen C Smith

16 Nov 2017
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Stephen C Smith

16 Nov 2017
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Stephen C Smith

16 Nov 2017
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Stephen C Smith

16 Nov 2017
21 CFR 820.22

Quality audits - auditor independence

Cited by Stephen C Smith

Inspected site

VSVipamat SASPloemeur, France

Inspection team

SCStephen C Smith

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations4x
21 CFR 820.22Cited across public-safe Form 483 observations4x

Full 483 report

Get the verbatim text of all 8 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