# FDA 483 - Qilu Pharmaceutical Co., Ltd. - February 22, 2018

Source: https://www.globalkeysolutions.net/records/483/qilu-pharmaceutical-co-ltd/b0e69ff8-9c21-4a99-8e64-a297561597b1

> FDA 483 for Qilu Pharmaceutical Co., Ltd. on February 22, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qilu Pharmaceutical Co., Ltd.
- Inspection Date: 2018-02-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Qilu Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredients manufacturer in Licheng, Jinan, Shandong, China, revealed significant deficiencies in their quality system. The firm failed to adequately investigate non-conformances and performed temperature mapping studies inadequately. These issues raise concerns about the quality and integrity of APIs distributed in the US.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)

Company: https://www.globalkeysolutions.net/companies/qilu-pharmaceutical-co-ltd/8313b57b-176c-41ab-89cc-e3dadfd3a0fc

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