# FDA 483 - Hanmi Pharma Co., Ltd - August 02, 2024

Source: https://www.globalkeysolutions.net/records/483/hanmi-pharma-co-ltd/6c69e1da-cd6f-4ea9-9cd8-879ae9ac5cd9

> FDA 483 for Hanmi Pharma Co., Ltd on August 02, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Hanmi Pharma Co., Ltd
- Inspection Date: 2024-08-02
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Hanmi Pharm. Co. Ltd. in Pyeongtaek, Gyeonggi, South Korea, a drug substance manufacturer, revealed two significant observations. The firm failed to perform complete analysis of procured materials at appropriate intervals and did not comprehensively test for contamination. Additionally, the company did not fully follow written procedures for monitoring processing steps, specifically failing to thoroughly and timely evaluate quality events and define change effectiveness parameters for a CAPA.

## Related Documents

- [483 - 2018-02-01](https://www.globalkeysolutions.net/records/483/hanmi-pharma-co-ltd/658a1814-5e4e-4311-9021-e5669c8c42d7)
- [EIR - 2021-06-02](https://www.globalkeysolutions.net/records/eir/hanmi-pharma-co-ltd/c8483b7c-f98a-40c9-9b01-7ee320338637)
- [483 - 2021-06-02](https://www.globalkeysolutions.net/records/483/hanmi-pharma-co-ltd/7e15c023-6590-4357-8670-f7643dc42017)
- [483 - 2022-07-05](https://www.globalkeysolutions.net/records/483/hanmi-pharma-co-ltd/a90a9884-ea18-4aae-aee7-6b308b7948ba)

## Related Officers

- [Investigator?](https://www.globalkeysolutions.net/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.globalkeysolutions.net/companies/hanmi-pharma-co-ltd/0b8e461e-f4bd-46f3-bb96-2148bf40df3c

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321