# FDA 483 - Qilu Pharmaceutical (Hainan) Co. Ltd. - August 22, 2025

Source: https://www.keypedia.com/records/483/qilu-pharmaceutical-hainan-co-ltd/08dbc3b0-c579-435b-991a-a9343a69dc78

> FDA 483 for Qilu Pharmaceutical (Hainan) Co. Ltd. on August 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qilu Pharmaceutical (Hainan) Co. Ltd.
- Inspection Date: 2025-08-22
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Qilu Pharmaceutical (Hainan) Co., Ltd. in Haikou, China, revealed significant deficiencies in their finished drug product manufacturing. Observations included a lack of validated control procedures for manufacturing processes, undersized equipment leading to operational errors, and the use of laboratory instruments that did not meet established specifications, specifically dissolution testers with asymmetrical basket rotation. These issues indicate potential risks to product quality and consistency.

## Related Documents

- [483 - 2019-11-06](https://www.keypedia.com/records/483/qilu-pharmaceutical-hainan-co-ltd/723eae93-3a14-4608-bbf6-fb6e3f0a7637)

## Related Officers

- [Investigator](https://www.keypedia.com/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)

Company: https://www.keypedia.com/companies/qilu-pharmaceutical-hainan-co-ltd/60dedaab-e32c-493a-894b-9eec7372c066

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8