Form 483

Avantor Performance Materials, LLC Form 483, 2016-10-24

FDA issued a Form 483 to Avantor Performance Materials, LLC on 2016-10-24 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Avantor Performance Materials, LLC · Paris, United States · Issued October 24, 2016

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

24 Oct 2016
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Kenneth E Felkley, Michael P Sheehan

24 Oct 2016
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Kenneth E Felkley, Michael P Sheehan

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.58Cited across public-safe Form 483 observations2x

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 2 observations

The source PDF and 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