# FDA 483 - Suzhou Suncadia Biopharmaceuticals Co., Ltd. - January 06, 2025

Source: https://www.globalkeysolutions.net/records/483/suzhou-suncadia-biopharmaceuticals-co-ltd/db6d8e6c-6a2a-422c-9d7d-4543c46fad07

> FDA 483 for Suzhou Suncadia Biopharmaceuticals Co., Ltd. on January 06, 2025. 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: 2025-01-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Suzhou Suncadia Biopharmaceuticals Co. Ltd. received a Form 483 following an FDA inspection, citing significant deficiencies in its manufacturing processes. The observations primarily concern inadequate procedures for preventing microbiological contamination, including issues with media fill validation, environmental monitoring, and aseptic processing systems. Additionally, the firm was cited for deficiencies in visual inspection procedures and the calibration and validation of automatic and electronic equipment, indicating a moderate level of severity regarding quality control and sterile manufacturing.

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## Related Officers

- [Jiangsong Jiang](https://www.globalkeysolutions.net/people/jiangsong-jiang/055e81c4-48a9-423d-b90f-ea0d08df79e1)
- [ Investigator, Consumer Safety Officer](https://www.globalkeysolutions.net/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Yiwei Li](https://www.globalkeysolutions.net/people/yiwei-li/e5ea2c24-8e1e-43be-be23-e276b8848cff)

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

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