FDA-Inspected Site

Syntec Scientific Corporation

6 FDA inspections are on record for Syntec Scientific Corporation in Shenkang Hsiang, Changhua Hsien, Taiwan.

Clean· No action indicated

Shenkang Hsiang, Changhua Hsien, Taiwan · Last updated August 15, 2026

Overview

  • 6 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-26.

At a glance

Inspections

6

Form 483s

3

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Mar 2026 – 26 Mar 2026Medical Devices & Rad HealthClean
2 May 2023 – 5 May 2023Medical Devices & Rad HealthClean
10 Dec 2018 – 13 Dec 2018Medical Devices & Rad Health483On file
15 Dec 2014 – 18 Dec 2014Medical Devices & Rad Health483View 483 →
1 Jul 2010Not recorded483View 483 →
5 May 2005Not recordedClean

Observations on record

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

18 Dec 2014
21 CFR 820.30(e)

Design review - Lack of or inadequate procedures

Cited by Elizabeth B Griffin

18 Dec 2014
21 CFR 820.30(g)

Design validation - user needs and intended uses

Cited by Elizabeth B Griffin

18 Dec 2014
21 CFR 820.100(b)

Documentation

Cited by Elizabeth B Griffin

18 Dec 2014
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Elizabeth B Griffin

18 Dec 2014
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Elizabeth B Griffin

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 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(e)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.70(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Syntec Scientific Corporation's 3 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