Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-09-25.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Sep 2019 – 25 Sep 2019 | Biologics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Sep 2019
21 CFR 123.8(a)(3)(ii)
Corrective action record review adequacy
Cited by Burnell M Henry, Allison A Wellman
25 Sep 2019
21 CFR 807.22(a)
Initial registration and listing
Cited by Burnell M Henry, Allison A Wellman
Investigators
FDA investigators tied to this site in the record.
Burnell M Henry1 insp.
Allison A Wellman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.8(a)(3)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.81(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 807.21(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 807.22(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Takeda's 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