Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-10-09.
At a glance
Inspections
3
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Sep 2014 – 9 Oct 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Mar 2011 | Not recorded | 483 | View 483 → |
| 21 Aug 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Oct 2014
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Tamara S Rosbury
9 Oct 2014
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Tamara S Rosbury
18 Mar 2011
21 CFR 820.30(g)
Design validation - software validation documentation
Cited by Stephen C Smith
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Boston Scientific Corporation's 2 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