FDA WARNING_LETTER - Cardionics SA - July 29, 2015

On October 16, 2015, the FDA issued a Warning Letter to Cardionics SA following a July 27-29, 2015 inspection in Brussels, Belgium. The inspection revealed that their CarTouch Portable ECG Electrocardiograph Device is adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 CFR Part 803 (Medical Device Reporting).

Key violations include: 1. **CAPA (21 CFR 820.100(a))**: Failure to adequately establish and maintain CAPA procedures, specifically lacking analysis of quality data sources, use of statistical methodology for recurring problems, and verification/validation of CAPA effectiveness. Eleven CAPAs initiated since 2013 were not verified/validated. The firm's response was inadequate, lacking a retrospective review of design files. 2. **Complaint Handling (21 CFR 820.198(a))**: Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints. The procedure did not ensure evaluation for MDR reportability, clear identification of MDR events, or complete complaint investigation