# FDA 483 - Evive Biopharmaceutical (Beijing), Ltd. - June 07, 2023

Source: https://www.keypedia.com/records/483/evive-biopharmaceutical-beijing-ltd/87b1727c-cc54-4864-bae5-00782ae476e8

> FDA 483 for Evive Biopharmaceutical (Beijing), Ltd. on June 07, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evive Biopharmaceutical (Beijing), Ltd.
- Inspection Date: 2023-06-07
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Evive Biotechnology (Beijing) Ltd, a drug substance manufacturer, was inspected by the FDA and received a Form 483 with seven observations. The inspection revealed significant deficiencies across multiple areas, including inadequate microbial contamination controls, environmental monitoring, cleanroom practices, deviation management, utility maintenance, temperature-controlled unit management, and good documentation practices. These issues indicate a systemic lack of control over critical manufacturing processes and quality systems.

## Related Officers

- [Wendy Tan, PhD, Microbiologist](https://www.keypedia.com/people/wendy-tan-phd-microbiologist/24f63b1c-33e5-440c-9853-2a18c141afa3)
- [Yingjun Fan, PhD, Chemist](https://www.keypedia.com/people/yingjun-fan-phd-chemist/32debe11-9b0d-4d78-94ea-25e207daaf3a)
- [Lane V. Christensen](https://www.keypedia.com/people/lane-v-christensen/fb30085e-494e-460e-9f3d-c480902d6468)

Company: https://www.keypedia.com/companies/evive-biopharmaceutical-beijing-ltd/34316aa6-0386-45be-883d-b7032a5cc0d0

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