Haw Par Healthcare Ltd.
Form 483 issued March 1, 2019 · Singapore, Singapore
- Inspection
- Feb 25 – Mar 1, 2019
- Investigator
- Justin A. Boyd
- Observations
- 14
- Pages
- 10
- FEI number
- 3001432470
In short: On March 1, 2019, FDA issued a Form 483 with 14 observations to Haw Par Healthcare Ltd. in Singapore, Singapore (FEI 3001432470) after an inspection that ran Feb 25 – Mar 1, 2019. The investigator was Justin A. Boyd. Most observations concern facilities & equipment and laboratory controls.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 03
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmHaw Par Healthcare Ltd. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Haw Par Healthcare Ltd.?
FDA listed 14 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Haw Par Healthcare Ltd.?
Justin A. Boyd is named on this Form 483, for the inspection of Feb 25 – Mar 1, 2019. Each investigator has a profile showing what they cite most.
When was Haw Par Healthcare Ltd. inspected by FDA?
The inspection ran Feb 25 – Mar 1, 2019, and the Form 483 is dated March 1, 2019.
How do I get the full Form 483 for Haw Par Healthcare Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.