Hanmi Pharm. Co., Ltd.
Form 483 issued July 5, 2022 · Pyeongtaek, South Korea
- Inspection
- Jun 27 – Jul 5, 2022
- Investigators
- Michael R. Shanks· Zhong Zhao
- Observations
- 2
- Pages
- 1
- FEI number
- 3009350213
In short: On July 5, 2022, FDA issued a Form 483 with 2 observations to Hanmi Pharm. Co., Ltd. in Pyeongtaek, South Korea (FEI 3009350213) after an inspection that ran Jun 27 – Jul 5, 2022. The investigators were Michael R. Shanks and Zhong Zhao. Most observations concern production; the most-cited regulation is 21 CFR 211.105 (equipment identification).
At a glance
Observations span 1 system, led by production.
Most cited: 21 CFR 211.105 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Temperature controlled storage area for cGMP…
- 02
Procedural controls for the handling and documentation of…
This inspection in context
Michael R. Shanks
27 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmHanmi Pharm. Co., Ltd. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.105
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hanmi Pharm. Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.105 (equipment identification). The opening words of each observation are shown on this page.
Who inspected Hanmi Pharm. Co., Ltd.?
Michael R. Shanks and Zhong Zhao are named on this Form 483, for the inspection of Jun 27 – Jul 5, 2022. Each investigator has a profile showing what they cite most.
When was Hanmi Pharm. Co., Ltd. inspected by FDA?
The inspection ran Jun 27 – Jul 5, 2022, and the Form 483 is dated July 5, 2022.
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.