Atlas

FDA-Inspected Site

Genentech, Inc.

8 FDA inspections are on record for Genentech, Inc. in Hillsboro, United States.

483· Form 483 issued

Hillsboro, United States · Last updated July 10, 2026

Overview

  • 8 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-04-19.

At a glance

Inspections

8

Form 483s

5

EIRs

3

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
11 Apr 2024 – 19 Apr 2024Human Drugs483View 483 →
17 May 2021 – 21 May 2021Human Drugs483On file
18 Jun 2018 – 5 Jul 2018Human Drugs483View 483 →
4 Apr 2016 – 15 Apr 2016Human Drugs483View 483 →
23 Jun 2014 – 1 Jul 2014Human DrugsClean
27 Jun 2012Not recorded483On file
17 Dec 2009Not recordedClean
14 Nov 2008Not recordedClean

Observations on record

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

19 Apr 2024
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Joey V Quitania, Philip F Istafanos, Joan M Cantellops Figueroa

19 Apr 2024
21 CFR 211.160(b)(4)

Establishment of calibration procedures

Cited by Joey V Quitania, Philip F Istafanos, Joan M Cantellops Figueroa

19 Apr 2024
21 CFR 211.186(a)

Master production and control records, procedure

Cited by Joey V Quitania, Philip F Istafanos, Joan M Cantellops Figueroa

19 Apr 2024
21 CFR 211.192

Written record of investigation incomplete

Cited by Joey V Quitania, Philip F Istafanos, Joan M Cantellops Figueroa

19 Apr 2024
21 CFR 211.194(a)(5)

Testing Calculations

Cited by Joey V Quitania, Philip F Istafanos, Joan M Cantellops Figueroa

Investigators

FDA investigators tied to this site in the record.

Barbara J Breithaupt3 insp.
Heika R Tait3 insp.
Gloria J Baca2 insp.
Joey V Quitania1 insp.
Philip F Istafanos1 insp.
Joan M Cantellops Figueroa1 insp.
Eileen A Liu1 insp.
Tracy K Li1 insp.
Don H Bark1 insp.
Anita Narula1 insp.
Kristopher J Stanya1 insp.
Sangeeta M Khurana1 insp.
Rebecca Rodriguez1 insp.
Bo Chi1 insp.
Donald C Obenhuber1 insp.
Lawrence Y Lee1 insp.
Nancy A Saxenian Emmons1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(5)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Genentech, Inc.'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