Overview
- 9 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-06.
At a glance
Inspections
9
Form 483s
8
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Oct 2023 – 6 Nov 2023 | Human Drugs | 483 | On file |
| 18 May 2023 – 24 May 2023 | Human Drugs | 483 | On file |
| 12 Jul 2021 – 19 Jul 2021 | Human Drugs | 483 | On file |
| 18 Nov 2019 – 26 Nov 2019 | Human Drugs | WL | View 483 → |
| 30 Oct 2017 – 7 Nov 2017 | Human Drugs | Clean | |
| 19 Oct 2015 – 30 Oct 2015 | Human Drugs | 483 | On file |
| 9 Sep 2013 – 18 Sep 2013 | Human Drugs | 483 | On file |
| 20 Jul 2012 | Not recorded | 483 | View 483 → |
| 29 Sep 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Nov 2019
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Ileana Barreto-Pettit, Steven M Weinman
26 Nov 2019
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Ileana Barreto-Pettit, Steven M Weinman
26 Nov 2019
21 CFR 211.165(f)
Failing drug products not rejected
Cited by Ileana Barreto-Pettit, Steven M Weinman
26 Nov 2019
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Ileana Barreto-Pettit, Steven M Weinman
26 Nov 2019
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Ileana Barreto-Pettit, Steven M Weinman
Investigators
FDA investigators tied to this site in the record.
Ileana Barreto-Pettit2 insp.
Michele Perry-Williams1 insp.
David J Gomes1 insp.
Laurimer Kuilan-Torres1 insp.
Thuy T Nguyen1 insp.
Vidya B Pai1 insp.
Holly Brevig1 insp.
Bingchen Du1 insp.
Jose E Melendez1 insp.
Vincent Thomas1 insp.
Steven M Weinman1 insp.
Lucas B Leake1 insp.
Angela E Glenn1 insp.
Santos E Camara1 insp.
Nicholas A Violand1 insp.
Xiaokuang Lai1 insp.
Juanita P Versace1 insp.
Kham Phommachanh1 insp.
Parul M Patel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Takeda Pharmaceutical Company Limited's 8 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