# FDA 483 - Pharmacyclics LLC - April 27, 2022

Source: https://www.keypedia.com/records/483/pharmacyclics-llc/13d32dfd-1ab9-4ca3-89ec-acf12f21e6aa

> FDA 483 for Pharmacyclics LLC on April 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmacyclics LLC
- Inspection Date: 2022-04-27
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Pharmacyclics LLC in South San Francisco, CA, received a Form FDA 483 with two observations following an inspection. The firm failed to provide written IND safety reports to participating investigators regarding potential serious risks associated with an investigational product. Additionally, the company did not adequately describe all transferred obligations to its Contract Research Organization, specifically concerning the return and disposition of study drugs.

## Related Officers

- [investigator](https://www.keypedia.com/people/dustin-r-abaonza/0a9994bd-d6ab-47cc-8f1b-5bf4d10bd852)

Company: https://www.keypedia.com/companies/pharmacyclics-llc/ac914c47-3023-4974-a8f2-6241d0db58b8

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b