FDA-Inspected Site

Alza Corporation

15 FDA inspections are on record for Alza Corporation in Vacaville, United States.

483· Form 483 issued

Vacaville, United States · Last updated July 10, 2026

Overview

  • 15 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2018-02-01.

At a glance

Inspections

15

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Jan 2018 – 1 Feb 2018Medical Devices & Rad Health483View 483 →
27 Jun 2016 – 29 Jun 2016Human DrugsClean
8 Sep 2014 – 19 Sep 2014Human Drugs483View 483 →
4 Mar 2014 – 14 Mar 2014Human Drugs483On file
18 Mar 2013 – 22 Mar 2013Human DrugsClean
12 Apr 2012Not recorded483View 483 →
27 Oct 2010Not recorded483On file
30 Oct 2009Not recordedClean
12 Jan 2009Not recordedClean
21 Jul 2008Not recordedClean
18 Jun 2008Not recordedClean
20 Mar 2008Not recordedClean

Observations on record

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

1 Feb 2018
21 CFR 211.182

Written records kept in individual logs

Cited by Lucila B Nwatu

1 Feb 2018
21 CFR 211.182

Written records kept in individual logs

Cited by Lucila B Nwatu

1 Feb 2018
21 CFR 211.68(b)

Computer control of master formula records

Cited by Lucila B Nwatu

1 Feb 2018
21 CFR 211.68(b)

Computer control of master formula records

Cited by Lucila B Nwatu

19 Sep 2014
21 CFR 211.100(b)

SOPs not followed / documented

Cited by John A Gonzalez

Investigators

FDA investigators tied to this site in the record.

Linda Thai1 insp.
Jennifer H Rhyu1 insp.
Kevin P Foley1 insp.
Daniel J Roberts1 insp.
Karen D Phung1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.182Cited across public-safe Form 483 observations2x
21 CFR 211.68(b)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Alza Corporation's 5 Form 483s

Source PDFs, 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