# FDA 483 - Hanmi Pharma Co., Ltd - June 02, 2021

Source: https://www.globalkeysolutions.net/records/483/hanmi-pharma-co-ltd/7e15c023-6590-4357-8670-f7643dc42017

> FDA 483 for Hanmi Pharma Co., Ltd on June 02, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hanmi Pharma Co., Ltd
- Inspection Date: 2021-06-02
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Hanmi Pharm. in Pyeongtaek-si, Republic of Korea, a drug substance manufacturer, revealed ten observations. The findings highlight significant inconsistencies in manufacturing processes, inadequate protocols for process control and validation, and deficiencies in documentation, CAPAs, and process understanding. These issues collectively indicate a lack of robust control over drug substance manufacturing, which could impact product quality.

## 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 - 2022-07-05](https://www.globalkeysolutions.net/records/483/hanmi-pharma-co-ltd/a90a9884-ea18-4aae-aee7-6b308b7948ba)
- [483 - 2024-08-02](https://www.globalkeysolutions.net/records/483/hanmi-pharma-co-ltd/6c69e1da-cd6f-4ea9-9cd8-879ae9ac5cd9)

## Related Officers

- [Richard Ledwidge, Ph.D., Biologist](https://www.globalkeysolutions.net/people/richard-ledwidge-phd-biologist/51161c1e-63da-4f24-bf8b-ecc1398c9dbe)
- [Zhang Zhao, PhD, Biologist](https://www.globalkeysolutions.net/people/zhang-zhao-phd-biologist/6b803e8b-1a94-49c5-9497-8e9bca172d91)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd