# FDA 483 - Tianjin Tianyao Pharmaceuticals Co., Ltd - May 31, 2019

Source: https://www.keypedia.com/records/483/tianjin-tianyao-pharmaceuticals-co-ltd/e8d56de2-1f6d-4bda-82b3-0d99a5c0bda7

> FDA 483 for Tianjin Tianyao Pharmaceuticals Co., Ltd on May 31, 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: 2019-05-31
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Tianjin Tianyao Pharmaceuticals Co., Ltd in Tianjin, China, revealed significant deficiencies in their manufacturing and laboratory operations. The firm failed to follow established environmental monitoring procedures for its Class D production area and maintained inadequate stability procedures for in-process products. Additionally, laboratory records for working standards were incomplete, lacking necessary requalification testing.

## Related Officers

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

Company: https://www.keypedia.com/companies/tianjin-tianyao-pharmaceuticals-co-ltd/bd9677d8-47f5-4b55-b70d-9ae123b68132

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