Hanmi Pharm. Co., Ltd.
FDA inspection history in Pyeongtaek, South Korea, 2018 to 2024
- 4
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2021: 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.
- 2018One Form 483, at Pyeongtaek, South Korea.
- 2021–24Three Form 483s, at Pyeongtaek, South Korea.
- 2021The longest 483 on file: 10 observations over 3 pages at Pyeongtaek, South Korea.
Cited most
Across all Hanmi Pharm. Co. observations on file
- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.105Equipment identification1
- 21 CFR 211.160General requirements1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Hanmi Pharm. Co. file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Pyeongtaek, South Korea
Four Form 483s · 2018 to 2024 · 15 observations
Latest: Form 483, Aug 2, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-02 | 483 Form 483 | Pyeongtaek, South Korea | 2 | $99 |
| 2022-07-05 | 483 Form 483 | Pyeongtaek, South Korea | 2 | $99 |
| 2021-06-02 | 483 Form 483 | Pyeongtaek, South Korea | 10 | $99 |
| 2018-02-01 | 483 Form 483 | Pyeongtaek, South Korea | 1 | $99 |
Investigators on these documents
FEI number 3009350213 · most recent document Aug 2, 2024
About Hanmi Pharm. Co., Ltd.
How many FDA Form 483s has Hanmi Pharm. Co., Ltd. received?
FDA Intel has 4 Form 483s on file for Hanmi Pharm. Co., Ltd.; the most recent is dated Aug 2, 2024.
When was Hanmi Pharm. Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Hanmi Pharm. Co., Ltd. is a Form 483 dated Aug 2, 2024, for the site in Pyeongtaek, South Korea.
What did FDA cite at Hanmi Pharm. Co., Ltd.?
The regulations cited most in the observations on file for Hanmi Pharm. Co., Ltd. are 21 CFR 211.100 (Written procedures; deviations), 5 times; 21 CFR 211.105 (Equipment identification), 1 time; 21 CFR 211.160 (General requirements), 1 time.