Atlas

Form 483

Sezim Grp Corp Form 483, 2013-04-03

FDA issued a Form 483 to Sezim Grp Corp on 2013-04-03 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Sezim Grp Corp · Chicago, United States · Issued April 3, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

3 Apr 2013
21 CFR 820.20(d)

Quality plan

Cited by Jesse A Vazquez, Michael R Giammanco

3 Apr 2013
21 CFR 820.50(a)

Evaluation of suppliers, contractors, etc., requirements

Cited by Jesse A Vazquez, Michael R Giammanco

Inspected site

SGSezim Grp CorpChicago, United States

Inspection team

JAJesse A Vazquez
MRMichael R Giammanco

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.20(d)Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

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