Atlas

FDA-Inspected Site

Wyeth Parenterals Divison of Wyeth Holdings Corp.

9 FDA inspections are on record for Wyeth Parenterals Divison of Wyeth Holdings Corp. in Carolina, United States.

Clean· No action indicated

Carolina, United States · Last updated July 11, 2026

Overview

  • 9 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2012-09-14.

At a glance

Inspections

9

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
14 Sep 2012Not recordedClean
29 Sep 2011Not recordedClean
30 Mar 2010Not recordedClean
29 Jun 2009Not recorded483View 483 →
26 May 2006Not recordedClean
23 Feb 2005Not recordedClean
29 Jun 2001Not recordedClean
26 Oct 2000Not recordedClean
6 Apr 2000Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

29 Jun 2009
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Rafael Gonzalez, Jorge L Lajara, Edwin Martinez

29 Jun 2009
21 CFR 211.165(a)

Testing and release for distribution

Cited by Rafael Gonzalez, Jorge L Lajara, Edwin Martinez

29 Jun 2009
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Rafael Gonzalez, Jorge L Lajara, Edwin Martinez

29 Jun 2009
21 CFR 211.192

Written record of investigation incomplete

Cited by Rafael Gonzalez, Jorge L Lajara, Edwin Martinez

Investigators

FDA investigators tied to this site in the record.

Ramon A Hernandez1 insp.
Rebecca Rodriguez1 insp.
Marianela Aponte Cruz1 insp.
Rafael Gonzalez1 insp.
Jorge L Lajara1 insp.
Edwin Martinez1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind this site's 1 Form 483

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat