Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-26.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jun 2026 – 26 Jun 2026 | Biologics | 483 | View 483 → |
| 16 Jan 2023 – 19 Jan 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Jan 2020 – 7 Feb 2020 | Human Drugs | 483 | View 483 → |
| 9 Apr 2019 – 11 Apr 2019 | Human Drugs | Clean | |
| 21 Apr 2016 – 28 Apr 2016 | Human Drugs | Clean | |
| 20 Mar 2014 – 28 Mar 2014 | Human Drugs | 483 | View 483 → |
| 12 May 2011 | Not recorded | 483 | On file |
| 16 Nov 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Jan 2023
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Maryam Tabatabaie
7 Feb 2020
21 CFR 211.188(b)(3)
Identification of each component or in-process material
Cited by Santos E Camara
Investigators
FDA investigators tied to this site in the record.
Emily B Camire1 insp.
Maryam Tabatabaie1 insp.
Santos E Camara1 insp.
MRA DavisM1 insp.
Vilmary Negron Rodriguez1 insp.
Christopher T Middendorf1 insp.
Carl A Huffman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Terumo BCT Ltd'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