# FDA 483 - Wanbang Biopharmaceuticals - September 08, 2023

Source: https://www.globalkeysolutions.net/records/483/wanbang-biopharmaceuticals/76373352-f34d-4509-8eae-ddc2c3492cd4

> FDA 483 for Wanbang Biopharmaceuticals on September 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wanbang Biopharmaceuticals
- Inspection Date: 2023-09-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Wanbang Biopharmaceuticals in Xuzhou, China, was inspected as a manufacturer of drug products, revealing significant deficiencies. The firm failed to establish and follow adequate procedures to prevent microbiological contamination during aseptic processing, including issues with RABS cleaning and technician sanitization. Additionally, the inspection found a failure to thoroughly investigate an Out-of-Specification assay discrepancy and noted deficient laboratory records lacking complete calculations for various tests.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.globalkeysolutions.net/companies/wanbang-biopharmaceuticals/06ce9dd3-f258-4095-ab7d-df66357273c3

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