Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-24.
At a glance
Inspections
10
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2024 – 24 May 2024 | Medical Devices & Rad Health | Clean | |
| 10 Mar 2022 – 30 Mar 2022 | Medical Devices & Rad Health | Clean | |
| 2 Mar 2021 – 12 Mar 2021 | Medical Devices & Rad Health | Clean | |
| 1 May 2017 – 31 May 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Sep 2014 – 19 Sep 2014 | Medical Devices & Rad Health | Clean | |
| 13 Feb 2013 – 13 Mar 2013 | Medical Devices & Rad Health | Clean | |
| 29 Dec 2011 | Not recorded | 483 | View 483 → |
| 9 Aug 2011 | Not recorded | Clean | |
| 24 Nov 2009 | Not recorded | 483 | On file |
| 4 Feb 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
31 May 2017
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Jacqueline S Warner
31 May 2017
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Jacqueline S Warner
Investigators
FDA investigators tied to this site in the record.
Jacqueline S Warner3 insp.
Paul E Stein3 insp.
Andrew J Garufi1 insp.
Yvette M Lacour-Davis1 insp.
Geoffrey K Kilili1 insp.
Michael G Mayfield1 insp.
Kimberley A Ricketts1 insp.
Gregson A Joseph1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | 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 Siemens Healthcare Diagnostics, Inc.'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