FDA WARNING_LETTER - Medrad Inc - February 03, 2011

On May 17, 2011, the FDA issued a Warning Letter to Medrad, Inc. following an inspection from January 4 to February 3, 2011, at their Indianola, Pennsylvania facility. The inspection revealed that Medrad's Avanta Fluid Management Injection System, a medical device, was misbranded under section 502(t)(2) of the Act.

The primary violation cited was the firm's failure to submit a written report to the FDA within 10 working days of initiating a correction or removal of a device to reduce a health risk, as required by 21 CFR 806.10(a)(b). Specifically, Medrad received 45 reports of alleged air injections with the Avanta system between January 1, 2007, and July 24, 2009. In response, Medrad implemented corrective actions including issuing a product safety reminder, releasing an advanced disposable set with a new pressure isolation valve, and upgrading software for one-step priming. However, there was no evidence that Medrad submitted a Correction and Removal report for these actions.

Medrad was instructed to take prompt action to correct these violations and notify the FDA in writing within fifteen business days of the specific steps taken, including documentation and a timetable for implementation. Failure to comply could result in regulatory actions such as seizure, injunction, and/or civil money penalties.