Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
18 Nov 2021
21 CFR 58.120(a)(9)
Protocol: tests, analyses, and measurements
Cited by Nicole C Victoria, Sharon L Matson
18 Nov 2021
21 CFR 58.195(b)
Archives: retention for appropriate time
Cited by Nicole C Victoria, Sharon L Matson
18 Nov 2021
21 CFR 58.33(b)
Study director: all data recorded and verified
Cited by Nicole C Victoria, Sharon L Matson
Inspected site
BSBoston Scientific CorporationSaint Paul, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.120(a)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.195(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.83 | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 5 observations
The source PDF, 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