# FDA 483 - Wuhan Humanwell Likang Pharmaceutical Co.,Ltd. - March 20, 2025

Source: https://www.keypedia.com/records/483/wuhan-humanwell-likang-pharmaceutical-coltd/bf8498e3-df99-4b55-8c7f-cb5157f605d7

> FDA 483 for Wuhan Humanwell Likang Pharmaceutical Co.,Ltd. on March 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wuhan Humanwell Likang Pharmaceutical Co.,Ltd.
- Inspection Date: 2025-03-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Hubei Honch Pharmaceutical Co, Ltd. in Huanggang, China, was inspected by the FDA from March 17-20, 2025. The inspection revealed two significant issues related to laboratory controls, specifically deficiencies in documenting testing method suitability and inadequate controls over computer systems to ensure authorized changes to control records. These observations indicate a lack of robust quality control in their analytical processes.

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