Overview
- 46 FDA inspections are on record.
- 13 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-15.
At a glance
Inspections
46
Form 483s
13
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 May 2026 – 15 May 2026 | Human Drugs | Clean | |
| 30 Mar 2026 – 7 Apr 2026 | Human Drugs | Clean | |
| 7 Apr 2025 – 21 Apr 2025 | Human Drugs | Clean | |
| 7 Apr 2025 – 18 Apr 2025 | Human Drugs | Clean | |
| 22 Apr 2024 – 2 May 2024 | Human Drugs | 483 | View 483 → |
| 12 Mar 2024 – 20 Mar 2024 | Human Drugs | Clean | |
| 4 Mar 2024 – 12 Mar 2024 | Human Drugs | 483 | View 483 → |
| 7 Aug 2023 – 11 Aug 2023 | Human Drugs | 483 | View 483 → |
| 14 Feb 2023 – 21 Feb 2023 | Human Drugs | Clean | |
| 26 Jan 2023 – 2 Feb 2023 | Human Drugs | 483 | On file |
| 29 Sep 2022 – 7 Oct 2022 | Human Drugs | Clean | |
| 17 May 2022 – 26 May 2022 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
2 May 2024
FDCA 505-1(f)(4)
Failure to comply with REMS Implementation System
Cited by Dustin R Abaonza, Sheilyn H Huang
Investigators
FDA investigators tied to this site in the record.
Dustin R Abaonza7 insp.
Jeffrey M Watson4 insp.
Maida Henesian3 insp.
Lance M De Souza3 insp.
Joan T Briones2 insp.
Stephanie A Slater2 insp.
Rebecca Rodriguez2 insp.
Thea C Grome2 insp.
Shelley H Beausoleil2 insp.
Jennifer H Rhyu2 insp.
Peter E Baker2 insp.
Henry K Lau2 insp.
Carl Lee2 insp.
Crystal Monroy1 insp.
Gunneet Kaur1 insp.
Sheilyn H Huang1 insp.
Joey V Quitania1 insp.
Walden H Lee1 insp.
Nicholas L Hunt1 insp.
Michael T Cyrus1 insp.
Scott N Lim1 insp.
Linh Tu1 insp.
Nayan J Patel1 insp.
Michael Shanks1 insp.
Yi Wang1 insp.
Andrea A Branche1 insp.
Thuy T Nguyen1 insp.
Jeanne M Fringer1 insp.
Christopher R Czajka1 insp.
Truong X Nguyen1 insp.
Rebecca T Davis1 insp.
Stuart W Russell1 insp.
Sherri J Jackson1 insp.
Anh Lac1 insp.
Peter S Kessler1 insp.
Timothy C Grome1 insp.
Aneel K Sandhu1 insp.
Eric L Dong1 insp.
Joshua S Hunt1 insp.
Sandra S Saniga1 insp.
William V Millar1 insp.
Mabel M Lee1 insp.
Kevin P Foley1 insp.
Daniel J Roberts1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.57(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Genentech, Inc.'s 13 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat