# FDA 483 - Jilin Asymchem Laboratories Co., Ltd. - April 12, 2019

Source: https://www.keypedia.com/records/483/jilin-asymchem-laboratories-co-ltd/425fa42d-5cd1-4300-8764-ced015e8f9ec

> FDA 483 for Jilin Asymchem Laboratories Co., Ltd. on April 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jilin Asymchem Laboratories Co., Ltd.
- Inspection Date: 2019-04-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Jilin Asymchem Laboratories Co., Ltd in Dunhua, Jilin, China, revealed significant deficiencies across multiple areas. The firm's laboratory equipment qualifications and software validations were found inadequate, particularly concerning data integrity and investigation of system errors. Additionally, cleaning validation protocols were insufficient, and laboratory investigations were not adequately performed, indicating a lack of robust quality control systems.

## Related Officers

- [Christopher S. Keating](https://www.keypedia.com/people/christopher-s-keating/94fcfd32-feb5-4b6c-80da-16202f4be01d)

Company: https://www.keypedia.com/companies/jilin-asymchem-laboratories-co-ltd/eab780e2-caef-4752-b3a8-19d9162c56d5

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