# FDA 483 - Tianjin Tianyao Pharmaceuticals Co., Ltd. - May 24, 2019

Source: https://www.globalkeysolutions.net/records/483/tianjin-tianyao-pharmaceuticals-co-ltd/1b7f892f-d219-4074-913a-f0dcc7b09074

> FDA 483 for Tianjin Tianyao Pharmaceuticals Co., Ltd. on May 24, 2019. 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: 2019-05-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Tianjin Tianyao Pharmaceuticals Co., Ltd, an API manufacturer in Tianjin, China, revealed significant deficiencies in laboratory controls and equipment maintenance. Observations included inadequate investigation of system suitability deviations, presence of particles in manufacturing equipment, and insufficient analytical procedures for starting materials and method validation for forced degradation studies. These issues suggest a lack of robust quality control and manufacturing oversight.

## Related Documents

- [483 - 2016-09-02](https://www.globalkeysolutions.net/records/483/tianjin-tianyao-pharmaceuticals-co-ltd/01ce9b3c-1866-4a23-93ea-1bf7a09b1631)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.globalkeysolutions.net/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1