Form 483

ABS Corporation Form 483, 2017-02-27

FDA issued a Form 483 to ABS Corporation on 2017-02-27 with 20 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health20 observations

ABS Corporation · Omaha, United States · Issued February 27, 2017

Overview

  • 20 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.

27 Feb 2017
21 CFR 211.192

Quality control unit review of records

Cited by Eric M Padgett

27 Feb 2017
21 CFR 211.192

Quality control unit review of records

Cited by Eric M Padgett

27 Feb 2017
21 CFR 211.192

Quality control unit review of records

Cited by Eric M Padgett

27 Feb 2017
21 CFR 211.192

Written record of investigation incomplete

Cited by Eric M Padgett

27 Feb 2017
21 CFR 211.192

Written record of investigation incomplete

Cited by Eric M Padgett

Inspected site

ACABS CorporationOmaha, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations8x
21 CFR 211.198(a)Cited across public-safe Form 483 observations4x
21 CFR 211.68(a)Cited across public-safe Form 483 observations4x
21 CFR 820.40(b)Cited across public-safe Form 483 observations4x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 20 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