Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-08-25.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Aug 2017 – 25 Aug 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 May 2014 – 20 May 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Oct 2011 | Not recorded | 483 | View 483 → |
| 1 Nov 2010 | Not recorded | 483 | View 483 → |
| 26 Jun 2008 | Not recorded | 483 | On file |
| 7 Apr 2004 | Not recorded | Clean | |
| 8 Nov 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Aug 2017
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Vicky L Cruz, Kathleen S Tormey
25 Aug 2017
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Vicky L Cruz, Kathleen S Tormey
25 Aug 2017
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Vicky L Cruz, Kathleen S Tormey
25 Aug 2017
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Vicky L Cruz, Kathleen S Tormey
25 Aug 2017
21 CFR 820.181
DMR - not or inadequately maintained
Cited by Vicky L Cruz, Kathleen S Tormey
Investigators
FDA investigators tied to this site in the record.
Linda F Murphy2 insp.
Janet Pulver2 insp.
Vicky L Cruz1 insp.
Kathleen S Tormey1 insp.
Marc A Jackson1 insp.
Bryan J Love1 insp.
Debra L Curtis1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.52(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.56 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Terumo BCT, Inc.'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