FDA 483 - Zhejiang Apeloa Biotechnology Co., Ltd - September 04, 2023

Zhejiang Apeloa Biotechnology Co., Ltd. in Dongyang, China, an animal drug API manufacturer, was cited for significant quality control issues during an FDA inspection. Observations included inadequate investigations into out-of-specification results and contamination, deficient laboratory OOS procedures that could permit retesting without scientific basis, and a water manufacturing system lacking proper validation and maintenance. These findings indicate a need for improved quality management and process control.