Hanmi Pharm. Co., Ltd.
Form 483 issued June 2, 2021 · Pyeongtaek, South Korea
- Observations
- 10
- Pages
- 3
- FEI number
- 3009350213
In short: On June 2, 2021, FDA issued a Form 483 with 10 observations to Hanmi Pharm. Co., Ltd. in Pyeongtaek, South Korea (FEI 3009350213). Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 3 systems, led by production.
Most cited: 21 CFR 211.100 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
SOP B:03.4034: Shutdown and Setup Program is inadequate to ensure batch consistency upon resuming…
- 03
The IT process performance protocol…
- 04
The Continued Process Verification Protocols P-FGCB-CPVP-01 (2.0), P-LFC-CPVP-01(1.0) and P- SGC-CPVP-01(1.0) to determine the state of…
This inspection in context
Questions about this 483
What did FDA find at Hanmi Pharm. Co., Ltd.?
FDA listed 10 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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 June 2, 2021.
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.