Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-27.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Apr 2026 – 27 Apr 2026 | Human Drugs | 483 | View 483 → |
| 27 Mar 2023 – 4 Apr 2023 | Human Drugs | 483 | On file |
| 11 Sep 2017 – 18 Sep 2017 | Human Drugs | Clean | |
| 20 Jul 2015 – 23 Jul 2015 | Human Drugs | Clean | |
| 9 Sep 2013 – 13 Sep 2013 | Human Drugs | 483 | On file |
| 27 May 2011 | Not recorded | 483 | On file |
| 8 Apr 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Apr 2026
21 CFR 211.160(b)(1)
Determination of conformance
Cited by Matthew B Casale, Saleem A Akhtar
27 Apr 2026
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Matthew B Casale, Saleem A Akhtar
Investigators
FDA investigators tied to this site in the record.
Matthew B Casale1 insp.
Saleem A Akhtar1 insp.
David A Oluwo1 insp.
Freddy Ortiz Colon1 insp.
Lisa Shin1 insp.
Veronica Fuentes1 insp.
Timothy T Kapsala1 insp.
Yumi J Hiramine1 insp.
Azza Talaat1 insp.
Steven M Weinman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Similasan AG's 4 Form 483s
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