Overview
- 14 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-14.
At a glance
Inspections
14
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jun 2024 – 14 Jun 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 May 2023 – 11 May 2023 | Medical Devices & Rad Health | Clean | |
| 22 Mar 2017 – 28 Mar 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Jun 2016 – 23 Jun 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Sep 2015 | Biologics | Clean | |
| 30 Jun 2014 – 11 Jul 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Mar 2012 | Not recorded | Clean | |
| 1 Sep 2011 | Not recorded | Clean | |
| 21 Dec 2010 | Not recorded | WL | View 483 → |
| 22 Apr 2010 | Not recorded | 483 | View 483 → |
| 3 Sep 2009 | Not recorded | 483 | On file |
| 11 Oct 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Jun 2024
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by David J Gasparovich, Felicia E Armbrustmacher
14 Jun 2024
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by David J Gasparovich, Felicia E Armbrustmacher
Investigators
FDA investigators tied to this site in the record.
Nancy A Bellamy2 insp.
David J Gasparovich1 insp.
Felicia E Armbrustmacher1 insp.
Preston M Lee1 insp.
Sargum C Sood1 insp.
Suyang Qin1 insp.
Matthew J Gretkierewicz1 insp.
Vesa Vuniqi1 insp.
Tracey L Siebesma1 insp.
Laureen F Kononen1 insp.
Thomas A Peter1 insp.
Brian P Putz1 insp.
Martha Sullivan Myrick1 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 | 4x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.20(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 50.25(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.43(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.43(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.45 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.7(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pioneer Surgical Technology Inc.'s 7 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