FDA 483 - Qilu Animal Health Products Co., Ltd. - July 26, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 100c4f92-5013-4308-a402-9e338b6c8281