FDA 483 - Baxter SA - September 27, 2019

An FDA inspection of Baxter SA in Lessines, Belgium, from September 19-27, 2019, revealed significant deficiencies across multiple areas of their manufacturing and quality control operations. Key issues included a lack of documented investigations for out-of-specification events and invalidated tests, failures in aseptic technique and gowning, and inadequate laboratory control mechanisms. The firm also failed to follow written production procedures, maintain proper ventilation, and ensure complete GMP training records, indicating a broad pattern of non-compliance with good manufacturing practices.