Atlas

Form 483

Otto Bock Healthcare Products GmbH Form 483, 2012-10-19

FDA issued a Form 483 to Otto Bock Healthcare Products GmbH on 2012-10-19 with 5 public-safe observations.

483· Form 483 issued5 observations

Otto Bock Healthcare Products GmbH · Vienna, Austria · Issued October 19, 2012

Overview

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

19 Oct 2012
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Dorothy W Lee

19 Oct 2012
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Dorothy W Lee

19 Oct 2012
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Dorothy W Lee

19 Oct 2012
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Dorothy W Lee

19 Oct 2012
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Dorothy W Lee

Inspected site

OBOtto Bock Healthcare Products GmbHVienna, Austria

Inspection team

DWDorothy W Lee

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 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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