Atlas

FDA-Inspected Site

Boston Scientific Corporation

15 FDA inspections are on record for Boston Scientific Corporation in Marlborough, United States.

483· Form 483 issued

Marlborough, United States · Last updated July 9, 2026

Overview

  • 15 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-11-26.

At a glance

Inspections

15

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
5 Nov 2024 – 26 Nov 2024Medical Devices & Rad Health483View 483 →
9 Jan 2023 – 13 Jan 2023Medical Devices & Rad HealthClean
1 Oct 2019 – 2 Oct 2019Medical Devices & Rad HealthClean
29 May 2019Medical Devices & Rad HealthClean
24 Oct 2018 – 31 Oct 2018Medical Devices & Rad HealthClean
13 Sep 2018 – 20 Sep 2018Medical Devices & Rad HealthClean
4 Dec 2017 – 6 Dec 2017Medical Devices & Rad Health483On file
18 Sep 2017 – 20 Sep 2017Medical Devices & Rad HealthClean
7 Jun 2017 – 9 Jun 2017Medical Devices & Rad HealthClean
16 May 2017 – 19 May 2017Medical Devices & Rad HealthClean
21 Jun 2016 – 12 Jul 2016Medical Devices & Rad HealthClean
17 Oct 2013 – 24 Oct 2013Medical Devices & Rad HealthClean

Observations on record

Form 483 observations cited at this site, most recent first.

26 Nov 2024
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Sara M Onyango

26 Nov 2024
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Sara M Onyango

26 Nov 2024
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Sara M Onyango

Investigators

FDA investigators tied to this site in the record.

MDSAP harperd4 insp.
Matthew C Watson2 insp.
MDSAP WilliamsA2 insp.
Darin S Wiegers2 insp.
Sara M Onyango1 insp.
Eric C Schmitt1 insp.
Michael P Anthony1 insp.
John A Sciacchitano1 insp.
Tina A Desorcy1 insp.
Sandra P White1 insp.
Stephen C Smith1 insp.
Michael P Sweeney1 insp.
Elizabeth B Griffin1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Boston Scientific Corporation's 4 Form 483s

Source PDFs 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