Overview
- 6 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2017-05-18.
At a glance
Inspections
6
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 May 2017 – 18 May 2017 | Medical Devices & Rad Health | Clean | |
| 20 Jul 2015 – 21 Jul 2015 | Medical Devices & Rad Health | Clean | |
| 15 Dec 2014 – 19 Dec 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Nov 2007 | Not recorded | Clean | |
| 1 Aug 2003 | Not recorded | Clean | |
| 18 Aug 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Dec 2014
21 CFR 820.40
Procedures not adequately established or maintained
Cited by Sean R Moynihan, Marc S Neubauer
19 Dec 2014
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Sean R Moynihan, Marc S Neubauer
19 Dec 2014
21 CFR 820.70(i)
Software validation for automated processes
Cited by Sean R Moynihan, Marc S Neubauer
19 Dec 2014
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Sean R Moynihan, Marc S Neubauer
19 Dec 2014
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Sean R Moynihan, Marc S Neubauer
Investigators
FDA investigators tied to this site in the record.
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 | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | 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 Fisher Diagnostics' 1 Form 483
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