FDA-Inspected Site

Haw Par Healthcare Ltd.

6 FDA inspections are on record for Haw Par Healthcare Ltd. in Singapore, Singapore.

483· Form 483 issued

Singapore, Singapore · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-09-27.

At a glance

Inspections

6

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Sep 2024 – 27 Sep 2024Human Drugs483View 483 →
15 Aug 2022 – 19 Aug 2022Human Drugs483View 483 →
25 Feb 2019 – 1 Mar 2019Human DrugsWLView 483 →
23 May 2016 – 26 May 2016Human Drugs483View 483 →
24 Mar 2014 – 28 Mar 2014Human Drugs483View 483 →
29 Oct 2009Not recordedWLOn file

Observations on record

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

27 Sep 2024
21 CFR 211.111

Establishment of time limitations

Cited by Tamil Arasu, Samantha E Cleek

27 Sep 2024
21 CFR 211.130(c)

Lot or control number assigned

Cited by Tamil Arasu, Samantha E Cleek

27 Sep 2024
21 CFR 211.165(b)

Microbiological testing

Cited by Tamil Arasu, Samantha E Cleek

27 Sep 2024
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Tamil Arasu, Samantha E Cleek

27 Sep 2024
21 CFR 211.198(b)(3)

Reason for Not Conducting Complaint Investigation

Cited by Tamil Arasu, Samantha E Cleek

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 211.111Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)Cited across public-safe Form 483 observations3x
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.110(a)Cited across public-safe Form 483 observations2x
21 CFR 211.130(c)Cited across public-safe Form 483 observations2x
21 CFR 211.142(b)Cited across public-safe Form 483 observations2x
21 CFR 211.186(a)Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 211.80(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.137(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(11)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.22(c)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(c)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 211.80(d)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Haw Par Healthcare Ltd.'s 6 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