Form 483

CSL Behring GmbH Form 483, 2024-04-18

FDA issued a Form 483 to CSL Behring GmbH on 2024-04-18 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

CSL Behring GmbH · Marburg, Germany · Issued April 18, 2024

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.

18 Apr 2024
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Joshua J Silvestri

Inspected site

CBCSL Behring GmbHMarburg, Germany

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 1 observation

The source PDF, 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