Haw Par Healthcare Ltd.
Form 483 issued August 19, 2022 · Singapore, Singapore
- Inspection
- Aug 15 – Aug 19, 2022
- Observations
- 8
- Pages
- 6
- FEI number
- 3001432470
In short: On August 19, 2022, FDA issued a Form 483 with 8 observations to Haw Par Healthcare Ltd. in Singapore, Singapore (FEI 3001432470) after an inspection that ran Aug 15 – Aug 19, 2022. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Written production and process control procedures are not followed in the execution of production and. process…
This inspection in context
Questions about this 483
What did FDA find at Haw Par Healthcare Ltd.?
FDA listed 8 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Haw Par Healthcare Ltd. inspected by FDA?
The inspection ran Aug 15 – Aug 19, 2022, and the Form 483 is dated August 19, 2022.
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.