Atlas

Form 483

Wyeth Lederle SRL Form 483, 2012-07-20

FDA issued a Form 483 to Wyeth Lederle SRL on 2012-07-20 with 3 public-safe observations.

483· Form 483 issued3 observations

Wyeth Lederle SRL · Catania, Italy · Issued July 20, 2012

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.

20 Jul 2012
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Joel D Hustedt

20 Jul 2012
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Joel D Hustedt

20 Jul 2012
21 CFR 211.192

Written record of investigation incomplete

Cited by Joel D Hustedt

Inspected site

WLWyeth Lederle SRLCatania, Italy

Inspection team

JDJoel D Hustedt

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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