Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-12.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Apr 2024 – 12 Apr 2024 | Human Drugs | Clean | |
| 1 Aug 2019 – 9 Aug 2019 | Human Drugs | 483 | View 483 → |
| 21 Aug 2017 – 29 Aug 2017 | Human Drugs | Clean | |
| 7 Sep 2015 – 18 Sep 2015 | Human Drugs | 483 | View 483 → |
| 2 Sep 2013 – 6 Sep 2013 | Human Drugs | 483 | View 483 → |
| 2 Aug 2012 | Not recorded | 483 | View 483 → |
| 14 Sep 2010 | Not recorded | 483 | View 483 → |
| 15 Aug 2008 | Not recorded | Clean | |
| 17 Oct 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Aug 2019
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Gam S Zamil, Patric C Klotzbuecher
9 Aug 2019
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Gam S Zamil, Patric C Klotzbuecher
9 Aug 2019
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Gam S Zamil, Patric C Klotzbuecher
9 Aug 2019
21 CFR 211.194(a)
Complete test data included in records
Cited by Gam S Zamil, Patric C Klotzbuecher
18 Sep 2015
21 CFR 211.194(a)
Complete test data included in records
Cited by Scott T Ballard, Susanne M Richardson
Investigators
FDA investigators tied to this site in the record.
John A Gonzalez1 insp.
Gam S Zamil1 insp.
Patric C Klotzbuecher1 insp.
Jeffrey P Raimondi1 insp.
Truong X Nguyen1 insp.
Scott T Ballard1 insp.
Susanne M Richardson1 insp.
Nicholas A Violand1 insp.
Xiaokuang Lai1 insp.
Ileana Barreto-Pettit1 insp.
Juanita P Versace1 insp.
Parul M Patel1 insp.
Dell S Moller1 insp.
Burnell M Henry1 insp.
Ann L Demarco1 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 | 4x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Takeda Pharmaceutical Company Limited'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