Overview
- 21 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-04.
At a glance
Inspections
21
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Oct 2024 – 4 Nov 2024 | Human Drugs | 483 | On file |
| 12 Feb 2024 – 16 Feb 2024 | Human Drugs | 483 | On file |
| 22 Jan 2024 – 25 Jan 2024 | Human Drugs | Clean | |
| 21 Jul 2022 – 27 Jul 2022 | Human Drugs | 483 | On file |
| 27 Jan 2020 – 31 Jan 2020 | Human Drugs | Clean | |
| 16 Apr 2018 – 24 Apr 2018 | Human Drugs | Clean | |
| 15 Sep 2016 – 23 Sep 2016 | Human Drugs | Clean | |
| 18 Jan 2016 – 22 Jan 2016 | Human Drugs | 483 | On file |
| 17 Mar 2014 – 28 Mar 2014 | Human Drugs | 483 | On file |
| 16 Sep 2011 | Not recorded | 483 | On file |
| 1 Mar 2011 | Not recorded | Clean | |
| 15 Apr 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Aug 2009
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jose A Cruz Gonzalez, Parul M Patel
28 Aug 2009
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Jose A Cruz Gonzalez, Parul M Patel
28 Aug 2009
21 CFR 211.56(b)
Written sanitation procedures not followed
Cited by Jose A Cruz Gonzalez, Parul M Patel
28 Aug 2009
21 CFR 211.56(c)
Written procedures lacking for use of pesticides etc.
Cited by Jose A Cruz Gonzalez, Parul M Patel
28 Aug 2009
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Jose A Cruz Gonzalez, Parul M Patel
Investigators
FDA investigators tied to this site in the record.
Reyes Candau-Chacon2 insp.
Thuy T Nguyen2 insp.
Holly Brevig1 insp.
Tawny L Colling1 insp.
Craig A Garmendia1 insp.
Michael A Charles1 insp.
Melissa D Ray1 insp.
Niketa Patel1 insp.
Anita Narula1 insp.
Michael E Maselli1 insp.
Samina S Khan1 insp.
Arsen Karapetyan1 insp.
Wayne E Seifert1 insp.
Rebecca E Dombrowski1 insp.
Christian Lynch1 insp.
Michelle Y Clark Stuart1 insp.
Patrick L Wisor1 insp.
Jose A Cruz Gonzalez1 insp.
Parul M Patel1 insp.
Torrance J Slayton1 insp.
Tina M Pawlowski1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind F. Hoffmann-La Roche AG's 7 Form 483s
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