Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-10-26.
At a glance
Inspections
11
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Oct 2020 – 26 Oct 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Mar 2016 – 30 Mar 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Mar 2015 – 9 Mar 2015 | Medical Devices & Rad Health | Clean | |
| 3 Mar 2014 – 7 Mar 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Aug 2013 – 3 Sep 2013 | Medical Devices & Rad Health | Clean | |
| 12 Dec 2011 | Not recorded | Clean | |
| 24 Jun 2010 | Not recorded | 483 | View 483 → |
| 19 Dec 2008 | Not recorded | 483 | View 483 → |
| 27 Jun 2008 | Not recorded | 483 | On file |
| 26 Jan 2007 | Not recorded | Clean | |
| 22 Aug 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Kirtida Patel2 insp.
Deborah A Greco2 insp.
Sonya L Karsik1 insp.
Kelvin Cheung1 insp.
Juanita Banuelos1 insp.
Cntrctmntr Anderson1 insp.
Scott K Zika1 insp.
Michael Araneta1 insp.
Vickie L Anderson1 insp.
Judy C Nepsa1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | 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(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | 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 this site's 6 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