Haw Par Healthcare Ltd.
Form 483 issued September 27, 2024 · Singapore, Singapore
- Inspection
- Sep 23 – Sep 27, 2024
- Investigators
- Samantha E. Cleek· Tamil Arasu
- Observations
- 7
- Pages
- 7
- FEI number
- 3001432470
In short: On September 27, 2024, FDA issued a Form 483 with 7 observations to Haw Par Healthcare Ltd. in Singapore, Singapore (FEI 3001432470) after an inspection that ran Sep 23 – Sep 27, 2024. The investigators were Samantha E. Cleek and Tamil Arasu. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
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
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
The drug product is not identified with a lot or control number that permits the determination…
- 04
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Samantha E. Cleek
4 documents · 2024–2025
Cites 211.165(b) (testing and release for distribution) more than any other section. Most of their documents are for sites in Georgia.
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 7 observations on this Form 483, mostly about quality system, materials and laboratory controls. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Haw Par Healthcare Ltd.?
Samantha E. Cleek and Tamil Arasu are named on this Form 483, for the inspection of Sep 23 – Sep 27, 2024. Each investigator has a profile showing what they cite most.
When was Haw Par Healthcare Ltd. inspected by FDA?
The inspection ran Sep 23 – Sep 27, 2024, and the Form 483 is dated September 27, 2024.
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.