Overview
- 13 public-safe observations are available for this inspection.
- 13 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.
22 Sep 2017
21 CFR 58.120(b)
Protocol: approval of changes
Cited by Nicole C Victoria, Sharon L Matson, Annabelle Crusan
22 Sep 2017
21 CFR 58.130(a)
Conduct: in accordance with protocol
Cited by Nicole C Victoria, Sharon L Matson, Annabelle Crusan
22 Sep 2017
21 CFR 58.185(a)(10)
Final report: names of those involved
Cited by Nicole C Victoria, Sharon L Matson, Annabelle Crusan
22 Sep 2017
21 CFR 58.195(b)
Archives: retention for appropriate time
Cited by Nicole C Victoria, Sharon L Matson, Annabelle Crusan
22 Sep 2017
21 CFR 58.29(a)
Personnel: education, training, experience
Cited by Nicole C Victoria, Sharon L Matson, Annabelle Crusan
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(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 58.195(b) | 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(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(a) | 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 |
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 13 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