Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-22.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Dec 2023 – 22 Dec 2023 | Human Drugs | 483 | View 483 → |
| 5 Jul 2021 – 9 Jul 2021 | Human Drugs | 483 | On file |
| 5 Nov 2019 – 8 Nov 2019 | Human Drugs | 483 | On file |
| 15 Jan 2019 – 18 Jan 2019 | Human Drugs | Clean | |
| 29 Jun 2015 – 2 Jul 2015 | Human Drugs | Clean | |
| 28 Sep 2007 | 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.
Jolanna A Norton1 insp.
Thuy T Nguyen1 insp.
Viviana Matta1 insp.
Zachary L Stamm1 insp.
Thao T Kwan1 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 211.192 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Daiichi Sankyo Co., Ltd.'s 3 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