# FDA 483 - Pucheng Chia Tai Biochemical Co. Ltd. - Putan Factory - April 18, 2025

Source: https://www.keypedia.com/records/483/pucheng-chia-tai-biochemical-co-ltd-putan-factory/5281c87b-c46c-498c-91fd-3a749878917f

> FDA 483 for Pucheng Chia Tai Biochemical Co. Ltd. - Putan Factory on April 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pucheng Chia Tai Biochemical Co. Ltd. - Putan Factory
- Inspection Date: 2025-04-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Pucheng Chia Tai Biochemistry Co., Ltd., Putian Factory, an Active Pharmaceutical Ingredient manufacturer, was inspected by the FDA. The inspection revealed significant issues with the Quality Unit's oversight of stability data for APIs, specifically regarding moisture content and risk assessments. Additionally, the firm failed to establish adequate document retention procedures, leading to the loss of critical alarm history.

## Related Officers

- [National Expert, Pharmaceutical](https://www.keypedia.com/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)

Company: https://www.keypedia.com/companies/pucheng-chia-tai-biochemical-co-ltd-putan-factory/dbec167d-d588-49dc-bd27-42205ea16011

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