Overview
- 22 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-07.
At a glance
Inspections
22
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Mar 2025 – 7 Apr 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Jul 2023 – 1 Aug 2023 | Medical Devices & Rad Health | Clean | |
| 21 Oct 2021 – 18 Nov 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Oct 2021 – 29 Oct 2021 | Medical Devices & Rad Health | Clean | |
| 24 Jul 2018 – 31 Jul 2018 | Medical Devices & Rad Health | Clean | |
| 8 Nov 2017 – 15 Nov 2017 | Medical Devices & Rad Health | Clean | |
| 7 Aug 2017 – 22 Sep 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Sep 2017 – 14 Sep 2017 | Medical Devices & Rad Health | Clean | |
| 18 Jul 2017 – 21 Jul 2017 | Medical Devices & Rad Health | Clean | |
| 31 May 2017 – 6 Jun 2017 | Medical Devices & Rad Health | Clean | |
| 9 Aug 2016 – 12 Aug 2016 | Medical Devices & Rad Health | 483 | On file |
| 15 Apr 2015 – 16 Apr 2015 | Medical Devices & Rad Health | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Apr 2025
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Christina L Bigham, Albert L Nguyen
7 Apr 2025
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Christina L Bigham, Albert L Nguyen
7 Apr 2025
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Christina L Bigham, Albert L Nguyen
7 Apr 2025
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Christina L Bigham, Albert L Nguyen
Investigators
FDA investigators tied to this site in the record.
Susan M Matthias5 insp.
Sharon L Matson4 insp.
Ralph W Jerndal3 insp.
Nicole C Victoria2 insp.
Marissa S Steinhagen2 insp.
Christina L Bigham1 insp.
Albert L Nguyen1 insp.
Benjamin W Anderson1 insp.
Timothy G Philips1 insp.
Kellie L Thommes1 insp.
Annabelle Crusan1 insp.
MDSAP WilliamsA1 insp.
MDSAP harperd1 insp.
April L Young1 insp.
Aimee J Edwin1 insp.
James A Beaulieu1 insp.
Marissa S Henning1 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 58.195(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.120(a)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.29(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.83 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.52(f)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.150(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | 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 Boston Scientific Corporation's 8 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