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Form 483

Catalent Pharma Solutions, LLC Form 483, 2011-03-29

FDA issued a Form 483 to Catalent Pharma Solutions, LLC on 2011-03-29 with 3 public-safe observations.

483· Form 483 issued3 observations

Catalent Pharma Solutions, LLC · Saint Petersburg, United States · Issued March 29, 2011

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

29 Mar 2011
21 CFR 211.22(b)

Adequate lab facilities not available

Cited by Kimberly M Hull

29 Mar 2011
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Kimberly M Hull

29 Mar 2011
21 CFR 211.182

Written records kept in individual logs

Cited by Kimberly M Hull

Inspected site

CPCatalent Pharma Solutions, LLCSaint Petersburg, United States

Inspection team

KMKimberly M Hull

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.22(b)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 3 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