Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-05-19.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 May 2023 – 19 May 2023 | Biologics | 483 | View 483 → |
| 30 Jan 2017 – 7 Feb 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Mar 2014 – 20 Mar 2014 | Human Drugs | 483 | On file |
| 16 Sep 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
19 May 2023
21 CFR 211.101(d)
Verification of component addition
Cited by Irina Gaberman, Brandon L Mariner
19 May 2023
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Irina Gaberman, Brandon L Mariner
19 May 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Irina Gaberman, Brandon L Mariner
19 May 2023
21 CFR 211.68(a)
Written calibration / inspection records not kept
Cited by Irina Gaberman, Brandon L Mariner
Investigators
FDA investigators tied to this site in the record.
Irina Gaberman1 insp.
Brandon L Mariner1 insp.
Angela E Glenn1 insp.
Uttaniti Limchumroon1 insp.
Matthew B Casale1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | 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