Genentech, Inc.
Form 483 issued May 26, 2022 · South San Francisco, California
- Inspection
- May 17 – May 26, 2022
- Investigators
- Andrea George· Jeanne Fringer· Riley Myers
- Observations
- 2
- Pages
- 3
- FEI number
- 2917293
In short: On May 26, 2022, FDA issued a Form 483 with 2 observations to Genentech, Inc. in South San Francisco, California (FEI 2917293) after an inspection that ran May 17 – May 26, 2022. The investigators were Andrea George, Jeanne Fringer, Riley Myers and Thuy T. Nguyen. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure…
- 02
The Quality Unit failed…
This inspection in context
Andrea George
2 documents · 2019–2022
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmGenentech, Inc. history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Genentech, Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls 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.?
Andrea George, Jeanne Fringer, Riley Myers and Thuy T. Nguyen are named on this Form 483, for the inspection of May 17 – May 26, 2022. Each investigator has a profile showing what they cite most.
When was Genentech, Inc. inspected by FDA?
The inspection ran May 17 – May 26, 2022, and the Form 483 is dated May 26, 2022.
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.