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Form 483

Abbott GmbH Form 483, 2010-09-23

FDA issued a Form 483 to Abbott GmbH on 2010-09-23 with 1 public-safe observation.

483· Form 483 issued1 observation

Abbott GmbH · Wiesbaden, Germany · Issued September 23, 2010

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

23 Sep 2010
21 CFR 820.50(a)

Evaluation of suppliers, contractors, etc., requirements

Cited by Terry C Kimball

Inspected site

AGAbbott GmbHWiesbaden, Germany

Inspection team

TCTerry C Kimball

Cited regulations

CFR citations associated with this Form 483.

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

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 1 observation

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