Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-15.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jun 2023 – 15 Jun 2023 | Medical Devices & Rad Health | Clean | |
| 3 Dec 2018 – 7 Dec 2018 | Medical Devices & Rad Health | Clean | |
| 8 Dec 2014 – 11 Dec 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Mar 2011 | Not recorded | Clean | |
| 25 Jun 2009 | Not recorded | 483 | View 483 → |
| 9 Jun 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jun 2009
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Catherine J Laufmann
25 Jun 2009
21 CFR 820.30(e)
Design review - Lack of or inadequate procedures
Cited by Catherine J Laufmann
25 Jun 2009
21 CFR 820.70(b)
Production and Process Change Procedures, lack of or Inad.
Cited by Catherine J Laufmann
25 Jun 2009
21 CFR 820.90(b)(2)
Product rework documentation, DHR {see also 820.184}
Cited by Catherine J Laufmann
Investigators
FDA investigators tied to this site in the record.
Adaliz Santaliz-Cruz1 insp.
Yehualashet A Gessesse1 insp.
Stephen D Eich1 insp.
James W Leonette1 insp.
Catherine J Laufmann1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Admedes GmbH's 2 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