Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-04.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Jun 2025 – 4 Jul 2025 | Human Drugs | 483 | View 483 → |
| 27 May 2019 – 31 May 2019 | Human Drugs | 483 | View 483 → |
| 11 Sep 2017 – 15 Sep 2017 | Human Drugs | 483 | View 483 → |
| 7 Apr 2014 – 11 Apr 2014 | Human Drugs | 483 | View 483 → |
| 17 Feb 2012 | Not recorded | 483 | View 483 → |
| 1 Apr 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
31 May 2019
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Saundrea A Munroe, Caroline Strasinger
31 May 2019
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Saundrea A Munroe, Caroline Strasinger
Investigators
FDA investigators tied to this site in the record.
Marian E Ramirez1 insp.
Saundrea A Munroe1 insp.
Caroline Strasinger1 insp.
Milva E Melendez1 insp.
Joel D Hustedt1 insp.
Alice S Tsao1 insp.
Jose R Hernandez1 insp.
Javier O Vega1 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 | 5x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hisamitsu Pharmaceutical Co., 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