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

Source: https://www.keypedia.com/records/483/point-biopharma-usa-inc/530b5998-d13e-4471-9be4-0fce34b92ddf

> FDA 483 for POINT Biopharma USA Inc. on June 07, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: POINT Biopharma USA Inc.
- Inspection Date: 2024-06-07
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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.

## Related Officers

- [Investigator](https://www.keypedia.com/people/muna-algharibeh/0f0dbd13-b36a-408d-8e42-4625f8de905d)
- [Matthew M. Schuckmann](https://www.keypedia.com/people/matthew-m-schuckmann/69dd0728-6b5d-41e7-834c-416e25a977dc)

Company: https://www.keypedia.com/companies/point-biopharma-usa-inc/f4a8cb71-7a5c-4407-a6c8-6765aacfb8da

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0