Overview
- 13 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-26.
At a glance
Inspections
13
Form 483s
7
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Sep 2025 – 26 Sep 2025 | Human Drugs | 483 | View 483 → |
| 19 Aug 2024 – 27 Aug 2024 | Human Drugs | 483 | On file |
| 24 Apr 2023 – 3 May 2023 | Human Drugs | Clean | |
| 28 Oct 2019 – 5 Nov 2019 | Human Drugs | 483 | On file |
| 26 Aug 2019 – 3 Sep 2019 | Human Drugs | Clean | |
| 4 Jun 2018 – 14 Jun 2018 | Human Drugs | 483 | On file |
| 19 Jun 2017 – 27 Jun 2017 | Human Drugs | 483 | On file |
| 10 Mar 2016 – 18 Mar 2016 | Human Drugs | 483 | View 483 → |
| 23 Jun 2014 – 1 Jul 2014 | Human Drugs | Clean | |
| 15 Jul 2013 – 20 Jul 2013 | Human Drugs | Clean | |
| 22 Jul 2010 | Not recorded | Clean | |
| 10 Jun 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Sep 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Justin A Boyd, Vivin George, Karen A Briggs
26 Sep 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Justin A Boyd, Vivin George, Karen A Briggs
26 Sep 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Justin A Boyd, Vivin George, Karen A Briggs
26 Sep 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Justin A Boyd, Vivin George, Karen A Briggs
26 Sep 2025
21 CFR 211.186(a)
Written procedures followed
Cited by Justin A Boyd, Vivin George, Karen A Briggs
Investigators
FDA investigators tied to this site in the record.
Justin A Boyd1 insp.
Vivin George1 insp.
Karen A Briggs1 insp.
Wayne E Seifert1 insp.
Santiago Gallardo Johnson1 insp.
Zhong Li1 insp.
Virginia A Carroll1 insp.
Zachary A Bogorad1 insp.
Emilie Kahn1 insp.
Luis M Burgos Medero1 insp.
Dennis Cantellops Paite1 insp.
Christina A Capacci-Daniel1 insp.
Kumar G Janoria1 insp.
Michael A Charles1 insp.
Roger F Zabinski1 insp.
Xiaohui Shen1 insp.
Zhihao Pete Qiu1 insp.
Samantha J Bradley1 insp.
Nicholas A Violand1 insp.
Chad N Thompson1 insp.
Francis A Guidry1 insp.
Joan A Loreng1 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 | 3x |
| 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 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Simtra 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