Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-08.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Mar 2026 – 8 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Jul 2017 – 20 Jul 2017 | Medical Devices & Rad Health | 483 | On file |
| 12 Jan 2016 – 22 Jan 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Jul 2015 – 29 Jul 2015 | Medical Devices & Rad Health | Clean | |
| 22 Apr 2013 – 25 Apr 2013 | Medical Devices & Rad Health | Clean | |
| 4 Feb 2010 | Not recorded | Clean | |
| 9 Oct 2008 | Not recorded | Clean | |
| 23 Aug 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Apr 2026
21 CFR 803.17
Lack of Written MDR Procedures
Cited by Janet Pulver, Linda Galindo, Jordan I Abel
8 Apr 2026
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Janet Pulver, Linda Galindo, Jordan I Abel
8 Apr 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Janet Pulver, Linda Galindo, Jordan I Abel
8 Apr 2026
ISO 13485:2016 Clause 4.1.5
Inadequate monitoring and control over outsourced processes
Cited by Janet Pulver, Linda Galindo, Jordan I Abel
8 Apr 2026
ISO 13485:2016 Clause 7.1
Records of risk management activities in product realization not maintained
Cited by Janet Pulver, Linda Galindo, Jordan I Abel
Investigators
FDA investigators tied to this site in the record.
James R Fleckenstein4 insp.
Janet Pulver2 insp.
Linda Galindo1 insp.
Jordan I Abel1 insp.
MDSAP harperd1 insp.
Vickie L Anderson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.5 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.3.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Boston Scientific Neuromodulation Corporation's 3 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