Atlas

FDA-Inspected Site

DHEF, Inc.

2 FDA inspections are on record for DHEF, Inc. in New Taipei City, Taiwan.

483· Form 483 issued

New Taipei City, Taiwan · Last updated July 10, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-23.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
20 Apr 2026 – 23 Apr 2026Medical Devices & Rad Health483On file
23 Jan 2017 – 26 Jan 2017Medical Devices & Rad Health483View 483 →

Observations on record

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

26 Jan 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Dawn M Braswell

26 Jan 2017
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Dawn M Braswell

26 Jan 2017
21 CFR 820.30(g)

Design validation - Risk analysis

Cited by Dawn M Braswell

26 Jan 2017
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Dawn M Braswell

Investigators

FDA investigators tied to this site in the record.

Sarah A Hassas1 insp.
Dawn M Braswell1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind DHEF, Inc.'s 2 Form 483s

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