Atlas

Form 483

Alza Corporation Form 483, 2012-04-12

FDA issued a Form 483 to Alza Corporation on 2012-04-12 with 1 public-safe observation.

483· Form 483 issued1 observation

Alza Corporation · Vacaville, United States · Issued April 12, 2012

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

12 Apr 2012
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Peter E Baker, Jeffrey M Watson

Inspected site

ACAlza CorporationVacaville, United States

Inspection team

PEPeter E Baker
JMJeffrey M Watson

Cited regulations

CFR citations associated with this Form 483.

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

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 1 observation

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