Overview
- 11 public-safe observations are available for this inspection.
- 11 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
BSBoston Scientific Neuromodulation CorporationValencia, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 483 report
Get the verbatim text of all 11 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere