Atlas

Form 483

Boule Medical AB Form 483, 2019-07-11

FDA issued a Form 483 to Boule Medical AB on 2019-07-11 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Boule Medical AB · Spanga, Sweden · Issued July 11, 2019

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.

11 Jul 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jesse A Vazquez

11 Jul 2019
21 CFR 820.20(a)

Management ensuring quality policy is understood

Cited by Jesse A Vazquez

Inspected site

BMBoule Medical ABSpanga, Sweden

Inspection team

JAJesse A Vazquez

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 820.20(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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