FDA 483 - Angiodynamics, Inc. - January 10, 2025

Angiodynamics, Inc. in Queensbury, NY, a medical device manufacturer, was cited for deficiencies in its complaint handling system during an FDA inspection. The firm's procedures for receiving and evaluating complaints were found to be inadequate, with numerous instances of delayed documentation. Additionally, records of complaint investigations lacked required information, specifically the dates of the investigations.