Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-05-14.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 May 2018 – 14 May 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 31 Oct 2016 – 10 Nov 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Apr 2014 – 5 May 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Jan 2013 | Not recorded | WL | View 483 → |
| 6 Nov 2009 | Not recorded | 483 | View 483 → |
| 20 Jun 2007 | Not recorded | Clean | |
| 16 Oct 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 May 2018
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Kathleen S Tormey
14 May 2018
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Kathleen S Tormey
14 May 2018
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Kathleen S Tormey
14 May 2018
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Kathleen S Tormey
Investigators
FDA investigators tied to this site in the record.
Christine I Shaw2 insp.
Kathleen S Tormey1 insp.
Alan P Kurtzberg1 insp.
Ashleigh P Wodushek1 insp.
Ashleigh P Barkans1 insp.
Thai T Duong1 insp.
Kimetha A King1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | 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 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(b) | 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 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Shippert Medical Technologies' 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