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483
•Tianjin Tianyao Pharmaceuticals Co., Ltd.•September 2, 2016

Tianjin Tianyao Pharmaceuticals Co., Ltd. – FDA 483, Sep 2, 2016

Record Details

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.

Company
Tianjin Tianyao Pharmaceuticals Co., Ltd.
Inspection date
September 2, 2016
Product type
drugs
Office
Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person
  • Sandra A. Hughes
View Company Profile

ID · 01ce9b3c-1866-4a23-93ea-1bf7a09b1631

Other documents for Tianjin Tianyao Pharmaceuticals Co., Ltd.
  • 483 - 2019-05-24May 24, 2019

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