Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-07.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Nov 2025 – 7 Nov 2025 | Human Drugs | Clean | |
| 11 Nov 2019 – 13 Nov 2019 | Human Drugs | 483 | View 483 → |
| 20 Jun 2018 – 22 Jun 2018 | Human Drugs | 483 | On file |
| 8 Sep 2014 – 12 Sep 2014 | Human Drugs | 483 | On file |
| 24 Feb 2012 | Not recorded | Clean | |
| 30 Jul 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Victoria Spivak1 insp.
Sangeeta M Khurana1 insp.
Lindsey M Schwierjohann1 insp.
Matthew B Casale1 insp.
Michael R Goga1 insp.
Jose A Cruz Gonzalez1 insp.
Ivis L Negron Torres1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sumika Chemical Analysis Service, Ltd.'s 4 Form 483s
Source PDFs 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