# FDA 483 - Yiling Pharmaceutical Ltd. - October 11, 2024

Source: https://www.keypedia.com/records/483/yiling-pharmaceutical-ltd/9d745478-ada0-449c-bae5-9687e10cb7c6

> FDA 483 for Yiling Pharmaceutical Ltd. on October 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yiling Pharmaceutical Ltd.
- Inspection Date: 2024-10-11
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Yiling Pharmaceutical Ltd. in Shijiazhuang, Hebei, China, a manufacturer of human drugs, was cited for significant deficiencies during an FDA inspection. Observations included inadequate cleaning of non-dedicated equipment leading to potential cross-contamination, failure to test incoming components before use, and incomplete re-qualification of an active pharmaceutical ingredient supplier. These issues indicate a lack of control over manufacturing processes and material quality.

## Related Documents

- [WARNING_LETTER - 2024-10-11](https://www.keypedia.com/records/warning_letter/yiling-pharmaceutical-ltd/092140d3-778c-4730-bcfc-85660fe5c929)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.keypedia.com/companies/yiling-pharmaceutical-ltd/3898272f-868b-4923-a0c2-dda78cbb789e

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8