Atlas

Form 483

Surgical Instruments Belgium SA (SIBEL S.A.) Form 483, 2017-03-30

FDA issued a Form 483 to Surgical Instruments Belgium SA (SIBEL S.A.) on 2017-03-30 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Surgical Instruments Belgium SA (SIBEL S.A.) · Gembloux, Belgium · Issued March 30, 2017

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

30 Mar 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Marc S Neubauer

30 Mar 2017
21 CFR 820.70(i)

Software validation for automated processes

Cited by Marc S Neubauer

30 Mar 2017
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Marc S Neubauer

Inspected site

SISurgical Instruments Belgium SA (SIBEL S.A.)Gembloux, Belgium

Inspection team

MSMarc S Neubauer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.70(i)Cited across public-safe Form 483 observations1x
21 CFR 820.90(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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