FDA 483 - Qilu Animal Health Products Co., Ltd. - April 11, 2025

An FDA inspection of Qilu Animal Health Products Co., Ltd. in Jinan, China, a sterile veterinary drug manufacturer, revealed significant deficiencies in sterility assurance. Observations included inadequate laboratory testing for sterility and pyrogen-free requirements for drug product batches, and insufficient validation of sterilization processes to prevent microbiological contamination. These issues indicate a high risk of product contamination and non-compliance with sterile manufacturing standards.