# FDA 483 - Qilu Pharmaceutical Co., Ltd. (Dongjia Site) - June 12, 2023

Source: https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-dongjia-site/545b9a08-bcbc-48af-be2e-2affd5d07e91

> FDA 483 for Qilu Pharmaceutical Co., Ltd. (Dongjia Site) on June 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qilu Pharmaceutical Co., Ltd. (Dongjia Site)
- Inspection Date: 2023-06-12
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Qilu Pharmaceutical Co., Ltd.'s sterile API manufacturing facility in Jinan, China, revealed significant deficiencies in aseptic processing and environmental controls. Observations included a lack of air sampling, inadequate disinfection practices, particulate shedding from cleaning cloths, and poor facility organization. Furthermore, the firm failed to conduct thorough investigations into deviations and out-of-specification results, lacking justified root causes and preventative actions.

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## Related Officers

- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.keypedia.com/companies/qilu-pharmaceutical-co-ltd-dongjia-site/cc92034a-0571-4e14-b26d-03e2efd1cd97

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3