# FDA 483 - Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) - July 29, 2024

Source: https://www.keypedia.com/records/483/qilu-pharmaceutical-co-ltd-high-tech-zone-site/73c7dc58-8862-45e4-aa38-1b97f1768aad

> FDA 483 for Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) on July 29, 2024. 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)
- Inspection Date: 2024-07-29
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Qilu Pharmaceutical Co.,Ltd in Jinan, Shandong, was inspected by the FDA from July 22-29, 2024. The inspection revealed that the firm did not validate all test methods. Specifically, a dissolution analytical method, which is reported on the Certificate of Analysis for their product, was not validated.

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## Related Officers

- [Tonia F. Bernard](https://www.keypedia.com/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

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/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8