# FDA 483 - Puma Biotechnology, Inc. - May 24, 2019

Source: https://www.keypedia.com/records/483/puma-biotechnology-inc/ed2d3888-523b-4e85-a89d-f47023cb0716

> FDA 483 for Puma Biotechnology, Inc. on May 24, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Puma Biotechnology, Inc.
- Inspection Date: 2019-05-24
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Puma Biotechnology, Inc. in Los Angeles, CA, was cited for failing to ensure proper monitoring of a clinical study. The inspection revealed significant issues with incorrect subject stratification and the Medical Monitor's oversight, leading to non-compliance with the study protocol. Furthermore, the firm did not include acknowledged stratification errors and a formal impact analysis in its clinical study report submitted to the FDA.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/ni-a-khin/31efd30a-c5ed-46ec-9522-19c8bd8ce12d)
- [investigator](https://www.keypedia.com/people/angela-shepas/743113c1-799b-44e9-9422-8049c476bfd2)
- [issuing_officer](https://www.keypedia.com/people/yangmin-ning/c3a6e1e3-6c5a-4a79-9438-1df682bcd7d0)

Company: https://www.keypedia.com/companies/puma-biotechnology-inc/003e999e-88e3-442b-bea7-8343b307740f

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6