FDA Intel

Genentech, Inc.

Form 483 issued July 5, 2018 · Hillsboro, Oregon

Inspection
Jun 18 – Jul 5, 2018
Investigators
Eileen A. Liu· Gloria J. Baca· Tracy K. Li
Observations
5
Pages
7
FEI number
3007232634

In short: On July 5, 2018, FDA issued a Form 483 with 5 observations to Genentech, Inc. in Hillsboro, Oregon (FEI 3007232634) after an inspection that ran Jun 18 – Jul 5, 2018. The investigators were Eileen A. Liu, Gloria J. Baca and Tracy K. Li. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).

At a glance

Laboratory controls and production account for 3 of 5 observations.

Laboratory controls2
Production1
Quality system1
Facilities & equipment1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…

  2. 02
    21 CFR 211.160(b)(4)

    Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…

  3. 03
    21 CFR 211.192

    There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…

  4. 04
    21 CFR 211.67(b)(2)

    Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Eileen A. Liu

41 documents · 2014–2026

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.

The firm

Genentech, Inc. history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Genentech, Inc.?

FDA listed 5 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.

Who inspected Genentech, Inc.?

Eileen A. Liu, Gloria J. Baca and Tracy K. Li are named on this Form 483, for the inspection of Jun 18 – Jul 5, 2018. Each investigator has a profile showing what they cite most.

When was Genentech, Inc. inspected by FDA?

The inspection ran Jun 18 – Jul 5, 2018, and the Form 483 is dated July 5, 2018.

How do I get the full Form 483 for Genentech, Inc.?

Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.

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