Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2013-05-16.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 May 2012 – 16 May 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Mar 2012 | Not recorded | WL | View 483 → |
| 13 Jul 2010 | Not recorded | Clean | |
| 16 Jul 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 May 2013
21 CFR 803.40(a)
Report of death, injury by marketed device
Cited by Angela Shepas, Charles L Larson
16 May 2013
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Angela Shepas, Charles L Larson
16 May 2013
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Angela Shepas, Charles L Larson
1 Mar 2012
21 CFR 806.20(b)(4)
Justification for not reporting
Cited by Angela Shepas, Vickie L Anderson
1 Mar 2012
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Angela Shepas, Vickie L Anderson
Investigators
FDA investigators tied to this site in the record.
Angela Shepas2 insp.
Charles L Larson1 insp.
Vickie L Anderson1 insp.
Herminio C Francisco1 insp.
Trudy R Papson1 insp.
Ruben G Abrajano1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Horiba Instruments, Inc dba Horiba Medical's 2 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