Atlas

FDA-Inspected Site

Vipamat SAS

5 FDA inspections are on record for Vipamat SAS in Ploemeur, France.

Clean· No action indicated

Ploemeur, France · Last updated August 15, 2026

Overview

  • 5 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-18.

At a glance

Inspections

5

Form 483s

3

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Mar 2026 – 18 Mar 2026Medical Devices & Rad HealthClean
23 Oct 2023 – 26 Oct 2023Medical Devices & Rad Health483View 483 →
13 Nov 2017 – 16 Nov 2017Medical Devices & Rad Health483View 483 →
1 Dec 2014 – 4 Dec 2014Medical Devices & Rad HealthClean
27 Jan 2011Not recorded483On file

Observations on record

Form 483 observations cited at this site, most recent first.

26 Oct 2023
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Joshua J Silvestri

26 Oct 2023
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Joshua J Silvestri

26 Oct 2023
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Joshua J Silvestri

26 Oct 2023
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Joshua J Silvestri

26 Oct 2023
21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by Joshua J Silvestri

Investigators

FDA investigators tied to this site in the record.

Wendy M Stone1 insp.
Joshua J Silvestri1 insp.
Stephen C Smith1 insp.
Charles N Dupont1 insp.
Richard L Rutherford1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations5x
21 CFR 820.22Cited across public-safe Form 483 observations4x
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.80(d)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Vipamat SAS' 3 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat