Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-07-16.
At a glance
Inspections
7
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jul 2021 – 16 Jul 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Apr 2018 – 13 Apr 2018 | Medical Devices & Rad Health | 483 | On file |
| 13 Feb 2018 – 21 Feb 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Dec 2016 – 19 Dec 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Jan 2016 – 5 Feb 2016 | Medical Devices & Rad Health | WL | View 483 → |
| 24 Mar 2015 – 26 Mar 2015 | Medical Devices & Rad Health | Clean | |
| 12 Feb 2014 – 18 Feb 2014 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Feb 2018
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by James M Simpson, Daniel R Tammariello
21 Feb 2018
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by James M Simpson, Daniel R Tammariello
Investigators
FDA investigators tied to this site in the record.
Marc S Neubauer3 insp.
Jude C Dike1 insp.
MDSAP harperd1 insp.
James M Simpson1 insp.
Daniel R Tammariello1 insp.
Cynthia A Harris1 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 820.250(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Qiagen Sciences LLC's 5 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