Overview
- 17 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-18.
At a glance
Inspections
17
Form 483s
6
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jul 2025 – 18 Jul 2025 | Human Drugs | Clean | |
| 31 Aug 2023 – 7 Sep 2023 | Human Drugs | Clean | |
| 14 Feb 2023 – 27 Feb 2023 | Human Drugs | Clean | |
| 13 Nov 2018 – 14 Nov 2018 | Human Drugs | Clean | |
| 16 May 2017 – 19 May 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 May 2015 – 6 May 2015 | Medical Devices & Rad Health | Clean | |
| 12 Nov 2014 – 19 Nov 2014 | Human Drugs | Clean | |
| 22 Sep 2014 – 26 Sep 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Feb 2013 – 25 Feb 2013 | Medical Devices & Rad Health | Clean | |
| 20 Jul 2012 | Not recorded | 483 | On file |
| 16 Jun 2011 | Not recorded | Clean | |
| 27 Oct 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 May 2017
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by James M Simpson
Investigators
FDA investigators tied to this site in the record.
Cynthia A Harris2 insp.
Erin L Mcfiren2 insp.
Hector J Colon-Torres2 insp.
Ann B Borromeo1 insp.
Melanie N Daniels1 insp.
Gabrielle J Swain1 insp.
Lucilla Facchin1 insp.
John Dan1 insp.
Danielle Pearson1 insp.
James M Simpson1 insp.
Marc S Neubauer1 insp.
Nebil A Oumer1 insp.
Patric C Klotzbuecher1 insp.
Merideth K Rose1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 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 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 812.140(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | 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