Atlas

Form 483

Catalent Anagni SRL Form 483, 2013-07-02

FDA issued a Form 483 to Catalent Anagni SRL on 2013-07-02 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Catalent Anagni SRL · Anagni, Italy · Issued July 2, 2013

Overview

  • 1 public-safe observation is 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.

2 Jul 2013
21 CFR 211.42(c)(10)(v)

Cleaning System

Cited by Marie F Morin, Carla A Norris

Inspected site

CACatalent Anagni SRLAnagni, Italy

Inspection team

MFMarie F Morin
CACarla A Norris

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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