# FDA 483 - Zoetis Suzhou Manufacturing Co., Ltd. - October 21, 2019

Source: https://www.keypedia.com/records/483/zoetis-suzhou-manufacturing-co-ltd/9521fb5c-0d20-420d-bc78-f7a9ede1c57d

> FDA 483 for Zoetis Suzhou Manufacturing Co., Ltd. on October 21, 2019. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zoetis Suzhou Manufacturing Co., Ltd.
- Inspection Date: 2019-10-21
- Product Type: veterinary
- Office Name: Office of Biological Products Operations - Division I
- Summary: Zoetis Suzhou Manufacturing Company Limited received a Form 483 for deficiencies in drug component testing, laboratory controls, and electronic record management. The inspection revealed issues with a reduced testing program for raw materials and APIs from a non-Zoetis facility, and inadequate method transfer protocols. Additionally, the firm failed to ensure proper backup and verification of electronic data and lacked adequate quality control procedures for automatic equipment.

## Related Officers

- [Angela Glenn](https://www.keypedia.com/people/angela-glenn/5ba5e1e2-883b-42c4-aae0-3564820723e8)

Company: https://www.keypedia.com/companies/zoetis-suzhou-manufacturing-co-ltd/82df778d-5d0e-4d7e-81bd-0e3fd850067b

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