FDA 483 - Qilu Animal Health Products Co., Ltd. - July 26, 2024

Qilu Animal Health Products Co., Ltd, a sterile drug manufacturer in Jinan, Shandong, China, was cited for significant deficiencies during an FDA inspection. Observations included inadequate aseptic processing procedures, deficient cleaning and disinfection protocols, and a critical lack of data integrity in environmental monitoring. The firm also failed to conduct scientifically sound investigations into discrepancies and maintain proper control over manufacturing processes and document changes.