FDA-Inspected Site

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.

3 FDA inspections are on record for Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Seberang Perai Selatan, Malaysia.

483· Form 483 issued

Seberang Perai Selatan, Malaysia · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-22.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
18 May 2026 – 22 May 2026Human Drugs483View 483 →
2 Mar 2026 – 5 Mar 2026Medical Devices & Rad HealthClean
5 Nov 2018 – 9 Nov 2018Medical Devices & Rad Health483On file

Observations on record

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

22 May 2026
21 CFR 211.192

Written record of investigation incomplete

Cited by Ashar P Parikh

22 May 2026
21 CFR 211.194(a)

Complete test data included in records

Cited by Ashar P Parikh

22 May 2026
21 CFR 211.68(b)

input/output verification

Cited by Ashar P Parikh

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind this site's 2 Form 483s

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