Atlas

Form 483

Wyeth Pharmaceuticals Llc Form 483, 2013-06-06

FDA issued a Form 483 to Wyeth Pharmaceuticals Llc on 2013-06-06 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Wyeth Pharmaceuticals Llc · Collegeville, United States · Issued June 6, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

6 Jun 2013
21 CFR 312.56(a)

Monitoring investigations

Cited by Tania E Vizcaino

6 Jun 2013
21 CFR 312.56(b)

Investigator non-compliance

Cited by Tania E Vizcaino

Inspected site

WPWyeth Pharmaceuticals LlcCollegeville, United States

Inspection team

TETania E Vizcaino

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.56(a)Cited across public-safe Form 483 observations1x
21 CFR 312.56(b)Cited across public-safe Form 483 observations1x

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