FDA WARNING_LETTER - STOCKERT GMBH - November 13, 2014

On April 14, 2015, the FDA issued a Warning Letter to Stockert GmbH following an inspection from November 10-13, 2014, at their Freiburg Im Breisgau, Germany facility. The inspection found that their RF SmartAblate System, a medical device, was misbranded under section 502(t)(2) of the Act due to failure to furnish required information under section 519 and 21 CFR Part 806.

Specifically, Stockert GmbH failed to submit a Report of Correction or Removal for a corrective action initiated on September 22, 2011 (CAPA report 481). This action involved replacing a power transistor in Electromagnetic Pulse radiofrequency generators to prevent malfunctions (loss of power) that could lead to patient injuries or burns, as indicated in their Risk Sheet #29. The firm's December 16, 2014, response did not address this violation.

Additionally, the inspection revealed deficiencies in the firm's quality system under 21 CFR Part 820. These included: 1. Failure to establish and maintain procedures for validating device design (21 CFR 820.30(g)), as evidenced by undocumented modifications to irrigation pump hardware used for design verification and validation. 2. Failure to establish and maintain rework procedures, including retesting and reevaluation of non