# FDA 483 - Anqiu Lu'an Pharmaceutical Co., Ltd. - September 22, 2025

Source: https://www.globalkeysolutions.net/records/483/anqiu-luan-pharmaceutical-co-ltd/f26acc1b-70c4-4404-a954-272c071563cd

> FDA 483 for Anqiu Lu'an Pharmaceutical Co., Ltd. on September 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anqiu Lu'an Pharmaceutical Co., Ltd.
- Inspection Date: 2025-09-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Anqiu Lu'an Pharmaceutical Co., Ltd., an API manufacturer in Weifang, China, revealed two significant observations. The firm's periodic electronic raw data review was found to be inadequate, lacking scientific rationale for sample size and assessment frequency. Additionally, the sampling methods for cleaning monitoring of equipment were deemed not scientifically sound, with critical areas not assessed during validation.

## Related Officers

- [Pharmaceutical Specialist/ Investigator ](https://www.globalkeysolutions.net/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)

Company: https://www.globalkeysolutions.net/companies/anqiu-luan-pharmaceutical-co-ltd/18b1a266-0f5f-46cc-99de-8ee48dd42b49

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