# FDA 483 - Zhejiang Tianyu Pharmaceutical Co. Ltd. - June 08, 2015

Source: https://www.keypedia.com/records/483/zhejiang-tianyu-pharmaceutical-co-ltd/e39d6fb3-8921-4883-aeaf-41ee6486dd58

> FDA 483 for Zhejiang Tianyu Pharmaceutical Co. Ltd. on June 08, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Tianyu Pharmaceutical Co. Ltd.
- Inspection Date: 2015-06-08
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Zhejiang Tianyu Pharmaceutical Co., LTD, an API manufacturer in Taizhou City, China, was cited for significant deficiencies during an FDA inspection. Observations included inadequate process controls and sampling procedures for drug substance manufacturing, insufficient statistical approaches for label sampling, and a lack of robust environmental monitoring systems for finished API storage. These issues collectively indicate a lack of assurance regarding product quality and process validation.

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Company: https://www.keypedia.com/companies/zhejiang-tianyu-pharmaceutical-co-ltd/b7ecf3cd-082c-48b5-94e1-8adeba7ce167

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