# FDA 483 - Suzhou Union Biopharm Co., Ltd. - May 26, 2023

Source: https://www.keypedia.com/records/483/suzhou-union-biopharm-co-ltd/72b0ef24-b8c6-4983-87f4-e4bae0c3c2fa

> FDA 483 for Suzhou Union Biopharm Co., Ltd. on May 26, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Suzhou Union Biopharm Co., Ltd.
- Inspection Date: 2023-05-26
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Suzhou Union Biopharma Co. Ltd. in Suzhou, China, a drug substance and drug product manufacturer, revealed significant deficiencies. Observations included inadequate procedures to prevent microbiological contamination during sterile drug product manufacturing, deficient quality unit oversight, and inadequate written procedures for record-keeping and quality reviews. These issues indicate a lack of control over critical manufacturing processes and quality systems.

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Company: https://www.keypedia.com/companies/suzhou-union-biopharm-co-ltd/5d9c9c07-1afc-44da-b4ff-872317d01143

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