Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-09-01.
At a glance
Inspections
9
Form 483s
5
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Aug 2022 – 1 Sep 2022 | Human Drugs | Clean | |
| 16 Apr 2018 – 24 Apr 2018 | Medical Devices & Rad Health | 483 | On file |
| 23 Jun 2016 – 1 Jul 2016 | Human Drugs | 483 | On file |
| 17 Jul 2014 – 25 Jul 2014 | Human Drugs | 483 | View 483 → |
| 14 Jun 2012 | Not recorded | 483 | On file |
| 9 Nov 2009 | Not recorded | 483 | On file |
| 23 May 2007 | Not recorded | Clean | |
| 24 Jun 2004 | Not recorded | Clean | |
| 15 Sep 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jul 2014
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Michael R Klapal, Nicole A Lloyd
Investigators
FDA investigators tied to this site in the record.
MRA McCulloughJ1 insp.
Margaret M Annes1 insp.
Dennis Cantellops Paite1 insp.
Katie L Penno1 insp.
Michael R Klapal1 insp.
Nicole A Lloyd1 insp.
Debra M Emerson1 insp.
Simone E Pitts1 insp.
Susan M Jackson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Siegfried Hameln Gmbh's 5 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