POINT Biopharma USA Inc.June 7, 2024

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

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Record Details

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.

Company: POINT Biopharma USA Inc.
Inspection Date: June 7, 2024
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations III
People: Matthew M. Schuckmann
Muna Algharibeh (Investigator)

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ID · 530b5998-d13e-4471-9be4-0fce34b92ddf