# FDA 483 - Suzhou Suncadia Biopharmaceuticals Co., Ltd. - December 14, 2023

Source: https://www.keypedia.com/records/483/suzhou-suncadia-biopharmaceuticals-co-ltd/937c9930-e489-4ff4-a31e-6a02b2f29d51

> FDA 483 for Suzhou Suncadia Biopharmaceuticals Co., Ltd. on December 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Inspection Date: 2023-12-14
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Suzhou Suncadia Biopharmaceuticals Co., Ltd. was cited for significant deficiencies across its drug substance and drug product manufacturing operations, particularly concerning aseptic processing, data integrity, and quality control. The inspection revealed issues with high-risk interventions in the vial fill line, inadequate data management and system access controls, and failures in preventing microbiological contamination. These observations indicate a systemic lack of robust procedures and controls necessary to ensure product quality, sterility, and data reliability.

## Related Documents

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## Related Officers

- [Zhang Zhao](https://www.keypedia.com/people/zhang-zhao/30c01178-37ff-446c-8ade-e3515627e723)
- [Richard Ledwidge](https://www.keypedia.com/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)
- [Yiwei Li](https://www.keypedia.com/people/yiwei-li/e5ea2c24-8e1e-43be-be23-e276b8848cff)

Company: https://www.keypedia.com/companies/suzhou-suncadia-biopharmaceuticals-co-ltd/97d76a60-5119-470a-bacf-c10c36a0ec51

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