Atlas

Form 483

Medi-Globe s.r.o. Form 483, 2018-05-24

FDA issued a Form 483 to Medi-Globe s.r.o. on 2018-05-24 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Medi-Globe s.r.o. · Hranice 1, Czech Republic · Issued May 24, 2018

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.

24 May 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by John A Sciacchitano

24 May 2018
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by John A Sciacchitano

24 May 2018
21 CFR 820.72(b)

Calibration procedures - content

Cited by John A Sciacchitano

Inspected site

MSMedi-Globe s.r.o.Hranice 1, Czech Republic

Inspection team

JAJohn A Sciacchitano

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 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.72(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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