FDA WARNING_LETTER - AngioDynamics, Inc. - January 13, 2011

The FDA issued a Warning Letter to AngioDynamics, Inc. following a January 4-13, 2011, inspection of their Queensbury, New York facility, which manufactures various medical devices including hemodialysis catheters. The inspection revealed that the Centros Chronic Hemodialysis Catheter Set was misbranded under section 502(t)(2) of the Act due to failures in Medical Device Reporting (MDR) and Reports of Corrections and Removals.

Specific violations include: 1. **Failure to include all reasonably known information in MDRs (21 CFR 803.50(b), 803.52):** For example, MDR #1319211-2010-00020 for an IRE Single Electrode Probe did not include information known from Complaint #100063. 2. **Failure to report deaths or serious injuries within 30 calendar days (21 CFR 803.50(a)(1)):** For instance, an event in Complaint #100055 involving the IRE System, known on February 25, 2010, was not reported until March 31, 2010. 3. **Failure to submit written reports for corrections or removals to reduce health risks (21 CFR 806.10(a