Genentech, Inc.
FDA inspection history in South San Francisco, California, 2011 to 2024
- 9
- Form 483s
Every document, by year
- Form 483
2011: three Form 483s; 2016: one Form 483; 2022: one Form 483; 2023: two Form 483s; 2024: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2011Three Form 483s, at South San Francisco, California.
- 2011The longest 483 on file: 6 observations over 3 pages at South San Francisco, California.
- 2016One Form 483, at South San Francisco, California.
- 2022–24Five Form 483s, at South San Francisco, California.
Cited most
Across all Genentech observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.192Production record review4
- 21 CFR 211.160General requirements2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.42(c)Design and construction features2
The complete Genentech file.
All 9 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
South San Francisco, California
Nine Form 483s · 2011 to 2024 · 27 observations
Latest: Form 483, May 2, 2024 →
Documents
9 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-02 | 483 Form 483 | South San Francisco, California | 1 | $99 |
| 2024-03-12 | 483 Form 483 | South San Francisco, California | 3 | $99 |
| 2023-08-11 | 483 Form 483 | South San Francisco, California | 1 | $99 |
| 2023-02-02 | 483 Form 483 | South San Francisco, California | 4 | $99 |
| 2022-05-26 | 483 Form 483 | South San Francisco, California | 2 | $99 |
| 2016-07-08 | 483 Form 483 | South San Francisco, California | 2 | $99 |
| 2011-09-27 | 483 Form 483 | South San Francisco, California | 4 | $99 |
| 2011-09-02 | 483 Form 483 | South San Francisco, California | 4 | $99 |
| 2011-06-23 | 483 Form 483 | South San Francisco, California | 6 | $99 |
Investigators on these documents
Peter E. Baker (3)William V. Millar (2)Carl Lee (1)Dustin R. Abaonza (1)He Nry- K. Lau (1)Henry K. Lau (1)Jeanne Fringer (1)Jeffrey M. Watson (1)Lance M. De Souza (1)Michael R. Shanks (1)Min-Shan-Ma Liu (1)Min-Shan-Ma Llu (1)
FEI number 2917293 · most recent document May 2, 2024
About Genentech, Inc.
How many FDA Form 483s has Genentech, Inc. received?
FDA Intel has 9 Form 483s on file for Genentech, Inc.; the most recent is dated May 2, 2024.
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 2, 2024, for the site in South San Francisco, California.
What did FDA cite at Genentech, Inc.?
The regulations cited most in the observations on file for Genentech, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.160 (General requirements), 2 times.