Genentech, Inc.
FDA inspection history in Hillsboro, Oregon, 2018 to 2021
- 2
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Hillsboro, Oregon.
- 2018The longest 483 on file: 5 observations over 7 pages at Hillsboro, Oregon.
- 2021One Form 483, at Hillsboro, Oregon.
Cited most
Across all Genentech observations on file
- 21 CFR 211.160(a)General requirements2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.67(b)(2)Equipment cleaning and maintenance1
The complete Genentech file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Hillsboro, Oregon
Two Form 483s · 2018 to 2021 · 5 observations
Latest: Form 483, May 21, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-05-21 | 483 Form 483 | Hillsboro, Oregon | — | $99 |
| 2018-07-05 | 483 Form 483 | Hillsboro, Oregon | 5 | $99 |
Investigators on these documents
Barbara J. Breithaupt (1)Eileen A. Liu (1)Gloria J. Baca (1)Tracy K. Li (1)
FEI number 3007232634 · most recent document May 21, 2021
About Genentech, Inc.
How many FDA Form 483s has Genentech, Inc. received?
FDA Intel has 2 Form 483s on file for Genentech, Inc.; the most recent is dated May 21, 2021.
When was Genentech, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Genentech, Inc. is a Form 483 dated May 21, 2021, for the site in Hillsboro, Oregon.
What did FDA cite at Genentech, Inc.?
The regulations cited most in the observations on file for Genentech, Inc. are 21 CFR 211.160(a) (General requirements), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time.