Atlas

Form 483

Medi-Globe GmbH Form 483, 2015-02-18

FDA issued a Form 483 to Medi-Globe GmbH on 2015-02-18 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Medi-Globe GmbH · Rosenheim, Germany · Issued February 18, 2015

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

18 Feb 2015
21 CFR 820.20(a)

Management ensuring quality policy is understood

Cited by Minh D Phan

18 Feb 2015
21 CFR 820.80(b)

Lack of or inadequate receiving acceptance procedures

Cited by Minh D Phan

Inspected site

MGMedi-Globe GmbHRosenheim, Germany

Inspection team

MDMinh D Phan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.20(a)Cited across public-safe Form 483 observations1x
21 CFR 820.80(b)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