# FDA 483 - Bloomage Biotechnology Corp., Ltd. - April 26, 2019

Source: https://www.globalkeysolutions.net/records/483/bloomage-biotechnology-corp-ltd/bbe500a9-bddd-436e-b34a-707edb2d3267

> FDA 483 for Bloomage Biotechnology Corp., Ltd. on April 26, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bloomage Biotechnology Corp., Ltd.
- Inspection Date: 2019-04-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Bloomage Biotechnology Corp., LTD., an API manufacturer in Jinan, China, revealed significant deficiencies in their quality control systems. Observations included failures in quality unit responsibilities regarding chromatographic data review, inadequate analytical method validation, and incomplete laboratory instrument calibration records. Additionally, the firm did not conduct appropriate laboratory tests for raw materials, intermediates, and APIs.

## Related Officers

- [Launner Rulon-Torres, CSO](https://www.globalkeysolutions.net/people/launner-rulon-torres-cso/c96787dc-64ca-4feb-8806-ea05013f458b)

Company: https://www.globalkeysolutions.net/companies/bloomage-biotechnology-corp-ltd/b641e3bc-e298-4b7e-b3aa-c49c46b69c0b

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