Genentech, Inc.
Form 483 issued May 21, 2021 · Hillsboro, Oregon
- Investigator
- Barbara J. Breithaupt
- Observations
- 1
- Pages
- 2
- FEI number
- 3007232634
In short: On May 21, 2021, FDA issued a Form 483 with 1 observation to Genentech, Inc. in Hillsboro, Oregon (FEI 3007232634). The investigator was Barbara J. Breithaupt. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established to monitor manufacturing processes that may be responsible for causing variability…
This inspection in context
Barbara J. Breithaupt
3 documents · 2014–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Montana.
The firmGenentech, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Genentech, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Genentech, Inc.?
Barbara J. Breithaupt is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Genentech, Inc. inspected by FDA?
This Form 483 is dated May 21, 2021.
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.