Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-01-12.
At a glance
Inspections
8
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jan 2023 – 12 Jan 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Jul 2022 – 11 Jul 2022 | Human Drugs | Clean | |
| 22 Feb 2018 – 2 Mar 2018 | Human Drugs | 483 | On file |
| 9 Oct 2017 – 13 Oct 2017 | Human Drugs | 483 | On file |
| 27 Jun 2016 – 5 Jul 2016 | Human Drugs | 483 | View 483 → |
| 7 Mar 2016 – 11 Mar 2016 | Human Drugs | 483 | On file |
| 10 Mar 2014 – 18 Mar 2014 | Human Drugs | Clean | |
| 16 Mar 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Jul 2016
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Linda F Murphy, Xiaoping Guan
5 Jul 2016
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Linda F Murphy, Xiaoping Guan
Investigators
FDA investigators tied to this site in the record.
Maryam Tabatabaie1 insp.
MRA B KambereM1 insp.
Michael Shanks1 insp.
Marion Michaelis1 insp.
Scott R Nichols1 insp.
Zhong Li1 insp.
Linda F Murphy1 insp.
Xiaoping Guan1 insp.
Reyes Candau-Chacon1 insp.
Paul L Bellamy1 insp.
Jennifer M Gogley1 insp.
Carla J Lundi1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sandoz GmbH's 6 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