Form 483

Ferring GmbH Form 483, 2019-08-23

FDA issued a Form 483 to Ferring GmbH on 2019-08-23 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Ferring GmbH · Kiel, Germany · Issued August 23, 2019

Overview

  • 2 public-safe observations are 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.

23 Aug 2019
21 CFR 211.165(e)

Test methods

Cited by Stephen D Brown

23 Aug 2019
21 CFR 211.165(e)

Test methods

Cited by Stephen D Brown

Inspected site

FGFerring GmbHKiel, Germany

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(e)Cited across public-safe Form 483 observations2x

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