Atlas

Form 483

Pro-Med Instruments Gmbh Form 483, 2012-06-21

FDA issued a Form 483 to Pro-Med Instruments Gmbh on 2012-06-21 with 3 public-safe observations.

483· Form 483 issued3 observations

Pro-Med Instruments Gmbh · Freiburg Im Breisgau, Germany · Issued June 21, 2012

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.

21 Jun 2012
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Terry C Kimball

21 Jun 2012
21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by Terry C Kimball

21 Jun 2012
21 CFR 820.198(b)

Review and evaluation for investigation

Cited by Terry C Kimball

Inspected site

PIPro-Med Instruments GmbhFreiburg Im Breisgau, Germany

Inspection team

TCTerry C Kimball

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(b)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.80(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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