Pharmacyclics LLCApril 27, 2022

FDA 483 - Pharmacyclics LLC - April 27, 2022

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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.

Company: Pharmacyclics LLC
Inspection Date: April 27, 2022
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West V
Person: Dustin R. Abaonza (investigator)

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ID · 13d32dfd-1ab9-4ca3-89ec-acf12f21e6aa