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Form 483

Supersonic Imagine, SA Form 483, 2014-11-06

FDA issued a Form 483 to Supersonic Imagine, SA on 2014-11-06 with 5 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health5 observations

Supersonic Imagine, SA · Aix En Provence Cedex 3, France · Issued November 6, 2014

Overview

  • 5 public-safe observations are available for this inspection.
  • 4 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.

6 Nov 2014
21 CFR 820.25(b)

Training records

Cited by Lydia S Chan

6 Nov 2014
21 CFR 820.30(g)

Design validation- Lack of or inadequate procedures

Cited by Lydia S Chan

6 Nov 2014
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Lydia S Chan

6 Nov 2014
21 CFR 820.198(a)

Complaints

Cited by Lydia S Chan

6 Nov 2014
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Lydia S Chan

Inspected site

SISupersonic Imagine, SAAix En Provence Cedex 3, France

Inspection team

LSLydia S Chan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.25(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 5 observations

The source PDF and every observation in full, 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