# FDA 483 - Taixing SynTheAll Pharmaceutical Co., Ltd - September 27, 2024

Source: https://www.keypedia.com/records/483/taixing-syntheall-pharmaceutical-co-ltd/5a201f3b-de8d-4696-92db-61a0b5237e10

> FDA 483 for Taixing SynTheAll Pharmaceutical Co., Ltd on September 27, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Taixing SynTheAll Pharmaceutical Co., Ltd
- Inspection Date: 2024-09-27
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Taixing SynTheAll Pharmaceutical Co., Ltd. revealed significant deficiencies in their manufacturing processes for Active Pharmaceutical Ingredients (API). The firm failed to qualify raw material suppliers, establish method validation programs, and implement a cleaning validation program for equipment. Additionally, equipment performance qualifications were inadequate, and a Master Batch Record for API production was absent, indicating systemic quality control issues.

## Related Officers

- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.keypedia.com/companies/taixing-syntheall-pharmaceutical-co-ltd/7acaa1ac-b9fc-4fed-8ac5-a6b413bdf3e1

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4