FDA 483 - ITG-Medev, Inc. - October 22, 2021

An FDA inspection of ITG-Medev, Inc. in San Francisco, CA, revealed significant deficiencies in their quality system. The firm failed to adequately document process validation activities, specifically regarding sterilization dosage ranges. Additionally, the inspection found that corrective and preventive action activities and their results were not documented, indicating a lack of control over quality issues.