# FDA 483 - Tianjin Tianyao Pharmaceuticals Co., Ltd. - September 02, 2016

Source: https://www.globalkeysolutions.net/records/483/tianjin-tianyao-pharmaceuticals-co-ltd/01ce9b3c-1866-4a23-93ea-1bf7a09b1631

> FDA 483 for Tianjin Tianyao Pharmaceuticals Co., Ltd. on September 02, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tianjin Tianyao Pharmaceuticals Co., Ltd.
- Inspection Date: 2016-09-02
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Tianjin Tianyao Pharmaceuticals Co., Ltd. in Tianjin, China, was inspected regarding its API manufacturing operations. The inspection revealed significant deficiencies across data integrity, water system monitoring, stability testing, cleaning validation, OOS investigations, and documentation practices. These issues indicate a lack of robust quality control and data management systems.

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## Related Officers

- [Sandra A. Hughes](https://www.globalkeysolutions.net/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

Company: https://www.globalkeysolutions.net/companies/tianjin-tianyao-pharmaceuticals-co-ltd/d4f41727-1d13-4054-8646-36d9aa8633a6

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