# FDA 483 - Zhejiang Regen Chemical Co., Ltd. - November 25, 2019

Source: https://www.keypedia.com/records/483/zhejiang-regen-chemical-co-ltd/41a96604-39db-41ee-a00c-69961f3b56e1

> FDA 483 for Zhejiang Regen Chemical Co., Ltd. on November 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Regen Chemical Co., Ltd.
- Inspection Date: 2019-11-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Zhejiang Regen Chemical Co., Ltd. in Taizhou, Zhejiang, revealed significant deficiencies in laboratory controls, data integrity, and quality systems. Observations included inadequate method validation, lack of system suitability testing, improper use of reference standards, and insufficient software security. Additionally, the firm failed to conduct stability testing, visually inspect reserve samples, and maintain detailed cleaning procedures.

## Related Officers

- [Laummer Kullan Torres](https://www.keypedia.com/people/laummer-kullan-torres/731852c1-9b11-403e-88d2-e087309bbe34)

Company: https://www.keypedia.com/companies/zhejiang-regen-chemical-co-ltd/22bcfe3a-710c-4371-b4ad-ff9f4b064cc1

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