Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-13.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Dec 2024 – 13 Dec 2024 | Human Drugs | 483 | On file |
| 13 Mar 2023 – 21 Mar 2023 | Human Drugs | 483 | View 483 → |
| 30 Jul 2018 – 1 Aug 2018 | Medical Devices & Rad Health | Clean | |
| 19 Jul 2018 – 25 Jul 2018 | Human Drugs | 483 | View 483 → |
| 1 Feb 2016 – 5 Feb 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Apr 2014 – 17 Apr 2014 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Mar 2023
21 CFR 211.110(b)
In-process conformity - examination, sample testing
Cited by Melanie W Pishnery, Marcellinus D Dordunoo
21 Mar 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Melanie W Pishnery, Marcellinus D Dordunoo
21 Mar 2023
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Melanie W Pishnery, Marcellinus D Dordunoo
21 Mar 2023
21 CFR 211.28(b)
Habits of good sanitation & health
Cited by Melanie W Pishnery, Marcellinus D Dordunoo
21 Mar 2023
21 CFR 211.42(c)(10)
Aseptic Processing Area
Cited by Melanie W Pishnery, Marcellinus D Dordunoo
Investigators
FDA investigators tied to this site in the record.
Ruo H Xu1 insp.
Zhong Li1 insp.
Melanie W Pishnery1 insp.
Marcellinus D Dordunoo1 insp.
Edward E Lockwood1 insp.
Ashar P Parikh1 insp.
Stephen D Eich1 insp.
Matthew J Morrison1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Terumo Corporation's 4 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