Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-08-09.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Aug 2017 – 9 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 1 Jun 2015 – 16 Jun 2015 | Medical Devices & Rad Health | 483 | On file |
| 13 Jan 2012 | Not recorded | 483 | View 483 → |
| 29 Oct 2010 | Not recorded | 483 | View 483 → |
| 16 Sep 2009 | Not recorded | 483 | View 483 → |
| 2 Jul 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Jan 2012
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Christine M Parmentier
29 Oct 2010
21 CFR 803.17(a)(2)
Lack of System for Determining MDR Events
Cited by Christine M Parmentier
16 Sep 2009
21 CFR 820.150(a)
Storage procedures to avoid release of unsuitable product
Cited by Timothy C Grome
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 820.150(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cepheid'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