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Form 483

Genentech, Inc. Form 483, 2012-10-23

FDA issued a Form 483 to Genentech, Inc. on 2012-10-23 with 1 public-safe observation.

483· Form 483 issued1 observation

Genentech, Inc. · South San Francisco, United States · Issued October 23, 2012

Overview

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

Inspectional observations

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

23 Oct 2012
21 CFR 312.50

Ensuring compliance with plan and protocol

Cited by Shelley H Beausoleil

Inspected site

GIGenentech, Inc.South San Francisco, United States

Inspection team

SHShelley H Beausoleil

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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