Overview
- 19 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-19.
At a glance
Inspections
19
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 May 2026 – 19 May 2026 | Biologics | 483 | View 483 → |
| 13 Nov 2023 – 20 Nov 2023 | Biologics | Clean | |
| 28 Nov 2022 – 6 Dec 2022 | Human Drugs | 483 | View 483 → |
| 26 Nov 2018 – 4 Dec 2018 | Biologics | 483 | View 483 → |
| 17 Sep 2018 – 21 Sep 2018 | Human Drugs | 483 | On file |
| 17 Aug 2017 – 24 Aug 2017 | Human Drugs | 483 | On file |
| 1 May 2017 – 9 May 2017 | Human Drugs | 483 | View 483 → |
| 8 Oct 2015 – 16 Oct 2015 | Biologics | 483 | On file |
| 27 Apr 2015 – 1 May 2015 | Human Drugs | Clean | |
| 17 Mar 2014 – 25 Mar 2014 | Human Drugs | Clean | |
| 22 Jun 2012 | Not recorded | 483 | On file |
| 2 Jul 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Dec 2022
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Edmund F Mrak, Wayne E Seifert
Investigators
FDA investigators tied to this site in the record.
Travis S Bradley2 insp.
Wayne E Seifert2 insp.
Kathleen R Jones1 insp.
Kula N Jha1 insp.
Jessica Chery1 insp.
Edmund F Mrak1 insp.
Mihaly S Ligmond1 insp.
Debra M Emerson1 insp.
Susan M Jackson1 insp.
Ademola O Daramola1 insp.
Don H Bark1 insp.
Cynthia Jim1 insp.
Michele L Forster1 insp.
Kham Phommachanh1 insp.
Zhong Li1 insp.
Seneca D Toms1 insp.
Thomas A Peter1 insp.
Xiaokuang Lai1 insp.
Kalavati C Suvarna1 insp.
Regina T Brown1 insp.
Jeffrey D Meng1 insp.
Kim L Thomas Cruse1 insp.
Michele L Obert1 insp.
Vlada Matusovsky1 insp.
Bruce H Mccullough1 insp.
Mei-Chiung J Huang1 insp.
Linda M Cherry1 insp.
Randy L Self1 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 | 4x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.130(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.82(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Novartis Pharma Stein AG's 9 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