Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-03.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Nov 2024 – 3 Dec 2024 | Human Drugs | 483 | View 483 → |
| 22 Oct 2018 – 1 Nov 2018 | Human Drugs | 483 | View 483 → |
| 17 Jan 2017 – 26 Jan 2017 | Human Drugs | 483 | View 483 → |
| 5 May 2014 – 13 May 2014 | Human Drugs | 483 | View 483 → |
| 12 Apr 2012 | Not recorded | Clean | |
| 24 Nov 2009 | Not recorded | Clean | |
| 19 Sep 2008 | Not recorded | 483 | On file |
| 8 Nov 2004 | Not recorded | Clean | |
| 15 Oct 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Nancy M Espinal2 insp.
Ankur C Patel1 insp.
James R Birkenstamm1 insp.
Frederick Razzaghi1 insp.
Maria Estrella1 insp.
Barbara J Wilimczyk-Macri1 insp.
Sean G Casey1 insp.
Russell J Glapion1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| FDCA 601(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SHISEIDO AMERICA INC.'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