FDA WARNING_LETTER - NeuroTherm, Inc. - April 26, 2012

On July 11, 2012, the FDA issued a Warning Letter to NeuroTherm, Inc. following an inspection from April 2-26, 2012. The inspection revealed that NeuroTherm's Reusable RF Electrodes and Radiofrequency products are adulterated under 21 U.S.C. § 351(h) because their manufacturing processes do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Design Validation (21 CFR 820.30(g)):** Failure to validate device design, specifically sterilization durability for Nitinol RF electrodes, despite instructions for reuse and adhesive data indicating limited sterilization cycles. NeuroTherm's response was inadequate, lacking validation studies or systemic corrections. 2. **Design Changes (21 CFR 820.30(i)):** Failure to adequately control design changes. Examples include changes to Nitinol material and the addition of a ferrule jacket, which affected device form but were not managed under design control procedures. An Engineering Change Order Procedure was also found to be non-existent. The firm's response was inadequate, lacking implementation evidence or a plan for creating the missing procedure. 3. **Design History File (DHF) (21 CFR 820.30(j)):** Failure to establish and maintain complete DHFs for multiple devices