Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2013-11-20.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Nov 2013 – 20 Nov 2013 | Human Drugs | Clean | |
| 8 Apr 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Apr 2011
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Linda F Murphy, Kimberley A Hoefen, Tamara L Setzer
8 Apr 2011
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Linda F Murphy, Kimberley A Hoefen, Tamara L Setzer
8 Apr 2011
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Linda F Murphy, Kimberley A Hoefen, Tamara L Setzer
8 Apr 2011
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Linda F Murphy, Kimberley A Hoefen, Tamara L Setzer
8 Apr 2011
21 CFR 211.198(a)
Procedures to be written and followed
Cited by Linda F Murphy, Kimberley A Hoefen, Tamara L Setzer
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| FDCA 760(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Similasan Experts' 1 Form 483
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