Haw Par Healthcare Ltd.
FDA inspection history in Singapore, Singapore, 2010 to 2024
- 3
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2010: one warning letter; 2019: one close-out letter and one Form 483; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One warning letter, at Singapore, Singapore.
- 2019One close-out letter and one Form 483, at Singapore, Singapore.
- 2019The longest 483 on file: 14 observations over 10 pages at Singapore, Singapore.
- 2022–24Two Form 483s, at Singapore, Singapore.
Cited most
Across all Haw Par Healthcare observations on file
- 21 CFR 211.100(a)Written procedures; deviations3
- 21 CFR 211.111Time limitations on production3
- 21 CFR 211.192Production record review3
- 21 CFR 211.80(a)General requirements3
- 21 CFR 211.130(c)Packaging and labeling operations2
The complete Haw Par Healthcare file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Singapore, Singapore
Three Form 483s, one close-out letter and one warning letter · 2010 to 2024 · 29 observations
Latest: Form 483, Sep 27, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-27 | 483 Form 483 | Singapore, Singapore | 7 | $99 |
| 2022-08-19 | 483 Form 483 | Singapore, Singapore | 8 | $99 |
| 2019-08-19 | Close-out Close-out letter | Singapore, Singapore | — | $99 |
| 2019-03-01 | 483 Form 483 | Singapore, Singapore | 14 | $99 |
| 2010-07-20 | Warning letter Warning letter | Singapore, Singapore | — | $99 |
Investigators on these documents
FEI number 3001432470 · most recent document Sep 27, 2024
About Haw Par Healthcare Ltd.
How many FDA Form 483s has Haw Par Healthcare Ltd. received?
FDA Intel has 3 Form 483s on file for Haw Par Healthcare Ltd.; the most recent is dated Sep 27, 2024.
When was Haw Par Healthcare Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Haw Par Healthcare Ltd. is a Form 483 dated Sep 27, 2024, for the site in Singapore, Singapore.
What did FDA cite at Haw Par Healthcare Ltd.?
The regulations cited most in the observations on file for Haw Par Healthcare Ltd. are 21 CFR 211.100(a) (Written procedures; deviations), 3 times; 21 CFR 211.111 (Time limitations on production), 3 times; 21 CFR 211.192 (Production record review), 3 times.
Has Haw Par Healthcare Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Haw Par Healthcare Ltd.; the most recent is dated Jul 20, 2010.