Hanmi Pharm. Co., Ltd.
Form 483 issued August 2, 2024 · Pyeongtaek, South Korea
- Observations
- 2
- Pages
- 2
- FEI number
- 3009350213
In short: On August 2, 2024, FDA issued a Form 483 with 2 observations to Hanmi Pharm. Co., Ltd. in Pyeongtaek, South Korea (FEI 3009350213). Most observations concern materials and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Materials and production account for 2 of 2 observations.
Most cited: 21 CFR 211.84 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complete analysis is not performed at appropriate intervals and compared with…
- 02
Written procedures established to monitor the progress and control the performance of processing steps that cause…
This inspection in context
Questions about this 483
What did FDA find at Hanmi Pharm. Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about materials and production. 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 Hanmi Pharm. Co., Ltd. inspected by FDA?
This Form 483 is dated August 2, 2024.
How do I get the full Form 483 for Hanmi Pharm. Co., 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.