# FDA 483 - Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) - Unknown Date

Source: https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/d67404c0-879f-4dd4-8407-58d014e644e8

> FDA 483 for Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Qilu Pharmaceutical Co. Ltd. in Jinan, Shandong, China, revealed significant deficiencies across multiple areas of their finished drug manufacturing operations. These issues include data integrity problems, inadequate environmental monitoring and aseptic processing controls, insufficient cleaning and disinfection procedures, and failures in quality control and laboratory practices. The findings indicate a broad lack of adherence to cGMP requirements, posing potential risks to product quality and sterility.

## Related Documents

- [483 - 2015-05-19](https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/537a5a2e-46c6-42b0-a116-3a7c6a18817d)
- [483 - 2017-09-20](https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/3d7aec8f-e0dc-4b88-82af-40bed46c9b2f)
- [483 - Unknown Date](https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/57f68425-186a-46f7-be58-9d26c4aa513d)

## Related Officers

- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Chemist at US Department of Health and Human Services](https://www.keypedia.com/people/felix-maldonado/d7a5c4bd-2aa7-405f-b3c4-17ef35152ab4)

Company: https://www.keypedia.com/companies/qilu-pharmaceutical-co-ltd-high-tech-zone-site/94263442-b5c4-4df8-b563-30ae0b9a4206

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd