Overview
- 10 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-16.
At a glance
Inspections
10
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jan 2025 – 16 Jan 2025 | Human Drugs | 483 | On file |
| 6 May 2019 – 14 May 2019 | Human Drugs | 483 | On file |
| 23 Feb 2017 – 3 Mar 2017 | Human Drugs | 483 | View 483 → |
| 9 May 2016 – 13 May 2016 | Human Drugs | Clean | |
| 7 Dec 2015 – 10 Dec 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Jun 2015 – 26 Jun 2015 | Human Drugs | 483 | On file |
| 2 Dec 2013 – 5 Dec 2013 | Human Drugs | Clean | |
| 24 Jun 2013 – 2 Jul 2013 | Human Drugs | 483 | On file |
| 30 Apr 2012 | Not recorded | Clean | |
| 14 Jul 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Dec 2015
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Karl D Hezel
Investigators
FDA investigators tied to this site in the record.
Thuy T Nguyen1 insp.
Madushini N Dharmasena1 insp.
Saleem A Akhtar1 insp.
Junho Pak1 insp.
Steven Fong1 insp.
Ruth A Moore1 insp.
Karl D Hezel1 insp.
Helen B Ricalde1 insp.
Steven M Weinman1 insp.
James M Mason1 insp.
Michelle J Glembin1 insp.
Sandra A Hughes1 insp.
Barbara D Paul1 insp.
Margaret M Annes1 insp.
Jeremy W Rotton1 insp.
Walden H Lee1 insp.
Minh D Phan1 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 | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sanofi-Aventis Deutschland GmbH's 7 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