FDA 483 - POINT Biopharma USA Inc. - June 07, 2024

POINT Biopharma USA Inc. in Indianapolis, IN, a sterile radioactive drug manufacturer, was inspected from May 29 to June 7, 2024. The inspection revealed a significant failure to test samples of each component for identity and conformity with specifications. Additionally, the firm failed to validate and establish the reliability of its component supplier's test analyses, relying on Certificates of Analysis without proper verification.