# FDA 483 - Hanmi Fine Chemical Co Ltd - June 11, 2018

Source: https://www.globalkeysolutions.net/records/483/hanmi-fine-chemical-co-ltd/b46966ce-2a31-4e12-a0b4-04e7abe570b9

> FDA 483 for Hanmi Fine Chemical Co Ltd on June 11, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hanmi Fine Chemical Co Ltd
- Inspection Date: 2018-06-11
- Product Type: drugs
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: Hanmi Fine Chemicals Co., Ltd., an API manufacturer in Gyeonggi-Do, Republic of Korea, was cited for significant deficiencies across its quality systems. Observations included inadequate cleaning validation, issues with stability sample storage and traceability, insufficient computer system controls, and failures in deviation management and equipment qualification. The firm also lacked documented training and sufficient data to support retest/expiry dates.

## Related Officers

- [National Program Expert- Pharmacy Compounding](https://www.globalkeysolutions.net/people/lucila-b-nwatu/3d1c9670-8206-425c-bddd-32e395293042)

Company: https://www.globalkeysolutions.net/companies/hanmi-fine-chemical-co-ltd/e3dca834-f5c7-45c6-87ba-625181f8fefb

Office: https://www.globalkeysolutions.net/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe