# FDA 483 - Tianjin Asymchem Pharmaceuticals Co., Ltd. - March 29, 2024

Source: https://www.globalkeysolutions.net/records/483/tianjin-asymchem-pharmaceuticals-co-ltd/70ec7c08-b1e3-48d5-8835-1912d7e16e61

> FDA 483 for Tianjin Asymchem Pharmaceuticals Co., Ltd. on March 29, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tianjin Asymchem Pharmaceuticals Co., Ltd.
- Inspection Date: 2024-03-29
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Tianjin Keynobels Pharmaceuticals Co., Ltd., a pharmaceutical manufacturer in Tianjin, P.R. China, was cited for significant deficiencies during an FDA inspection. Observations included inadequate personnel training and record-keeping, as well as incomplete batch production and control records. These issues indicate a lack of proper control over manufacturing processes and quality assurance.

## Related Documents

- [483 - 2019-12-06](https://www.globalkeysolutions.net/records/483/tianjin-asymchem-pharmaceuticals-co-ltd/93dc41ab-1075-4e3e-886b-7305749adeff)
- [483 - 2021-10-19](https://www.globalkeysolutions.net/records/483/tianjin-asymchem-pharmaceuticals-co-ltd/10943e20-ad7a-4315-8d4a-731ff65193d0)

## Related Officers

- [Saeed Abbasi](https://www.globalkeysolutions.net/people/saeed-abbasi/82ba11ef-85c7-49cd-b334-dd7cbc00d29e)

Company: https://www.globalkeysolutions.net/companies/tianjin-asymchem-pharmaceuticals-co-ltd/1e469779-31a9-40d3-9bd8-d580e8489e7b

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