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

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.