FDA 483 - Bio-Technology General (Israel), Ltd. - March 16, 2023

An FDA inspection of Bio-Technology General (Israel) Ltd (BTG) in Kiryat Malachi revealed significant deficiencies in their drug substance manufacturing. The firm experienced widespread microbial contamination, inadequate process controls for viral and microbial safety, and ineffective cleaning procedures. Additionally, issues were noted with facility design, equipment maintenance, documentation, investigations, and the effectiveness of corrective actions, indicating a lack of robust quality control.