# FDA 483 - Hanmi Pharma Co., Ltd - July 05, 2022

Source: https://www.globalkeysolutions.net/records/483/hanmi-pharma-co-ltd/a90a9884-ea18-4aae-aee7-6b308b7948ba

> FDA 483 for Hanmi Pharma Co., Ltd on July 05, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hanmi Pharma Co., Ltd
- Inspection Date: 2022-07-05
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: An FDA inspection of Hanmi Pharm. Co., Ltd., a drug substance manufacturer in Pyeongtaek-si, Gyeonggi-do, Republic of Korea, identified two observations. The firm was cited for an unqualified temperature-controlled storage area for cGMP materials and inadequate procedural controls for handling and documenting in-process materials.

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- [483 - 2024-08-02](https://www.globalkeysolutions.net/records/483/hanmi-pharma-co-ltd/6c69e1da-cd6f-4ea9-9cd8-879ae9ac5cd9)

## Related Officers

- [Zhong Zhao](https://www.globalkeysolutions.net/people/zhong-zhao/a8543d5d-c319-4e2f-a2e7-b9d25a94a405)
- [Investigator](https://www.globalkeysolutions.net/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

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

Office: https://www.globalkeysolutions.net/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0