# FDA 483 - Yibin Lihao Bio-technical Co., Ltd. - August 06, 2019

Source: https://www.keypedia.com/records/483/yibin-lihao-bio-technical-co-ltd/00c96394-8462-4328-a725-50c8d842d813

> FDA 483 for Yibin Lihao Bio-technical Co., Ltd. on August 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yibin Lihao Bio-technical Co., Ltd.
- Inspection Date: 2019-08-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Yibin Lihao Bio-technical Co., Ltd. in Yibin, China, an Intermediate API Manufacturer, was cited for significant deficiencies during an FDA inspection. The observations highlight severe issues with data integrity, including non-contemporaneous and missing batch records, and a lack of control over documentation. Furthermore, the firm demonstrated inadequate quality unit oversight, poor facility and equipment maintenance, and insufficient employee training, indicating a systemic breakdown in their manufacturing processes.

## Related Officers

- [Marijo B. Kambere](https://www.keypedia.com/people/marijo-b-kambere/54e010f0-0d56-4b20-b5e2-112e372de58b)

Company: https://www.keypedia.com/companies/yibin-lihao-bio-technical-co-ltd/d2bb3d4e-11dc-491b-9c89-e9221f5b188c

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1