Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-09-17.
At a glance
Inspections
9
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Sep 2018 – 17 Sep 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Mar 2017 – 13 Apr 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Jul 2015 – 30 Jul 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Aug 2012 | Not recorded | 483 | View 483 → |
| 14 Oct 2011 | Not recorded | 483 | View 483 → |
| 29 Dec 2010 | Not recorded | 483 | View 483 → |
| 15 Jun 2009 | Not recorded | Clean | |
| 8 Dec 2003 | Not recorded | Clean | |
| 31 Jul 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Sep 2018
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Matthew M Vernon, James R Montero
17 Sep 2018
21 CFR 820.90(b)(2)
Product rework procedures, Lack of or inadequate procedures
Cited by Matthew M Vernon, James R Montero
17 Sep 2018
21 CFR 820.90(b)(2)
Product rework procedures, Lack of or inadequate procedures
Cited by Matthew M Vernon, James R Montero
17 Sep 2018
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Matthew M Vernon, James R Montero
13 Apr 2017
21 CFR 803.17
Lack of Written MDR Procedures
Cited by Kathleen S Tormey, Matthew M Vernon, Christine I Shaw, Kimberly Lewandowski-Walker
Investigators
FDA investigators tied to this site in the record.
Matthew M Vernon2 insp.
James R Montero2 insp.
Kathleen S Tormey1 insp.
Christine I Shaw1 insp.
Kimberly Lewandowski-Walker1 insp.
Amanda S Zorn1 insp.
Ashleigh P Wodushek1 insp.
Janet Pulver1 insp.
Nathan R Moon1 insp.
Jennifer L Wolfe1 insp.
Jessie E Morris1 insp.
Ricki A Chase1 insp.
Debra L Curtis1 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 | 8x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.180 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.200(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | 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