Cardiac Designs Inc. – FDA Warning Letter, Jul 2, 2015

On June 16, 2015, the FDA inspected Cardiac Designs, Inc., a manufacturer of the ECG Check Application and ECG Check Wireless Lead Cardiac Monitor. The inspection revealed these devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Violations include: 1. **Failure to establish and maintain design validation procedures (21 CFR 820.30(g)):** No records demonstrated validation of the ECG Check Application software, despite procedures requiring it. 2. **Failure to establish complaint handling procedures (21 CFR 820.198):** The "Customer Requirements and Complaints" procedure was inadequate. It did not address the use of a contractor for initial complaint handling, nor how complaints were forwarded for investigation. At least 87 complaints were not documented on the required form, reviewed for investigation necessity, or evaluated for reportability under 21 CFR 803. A specific complaint regarding a possible device failure to detect an abnormal heart condition lacked evaluation for reportability or details of the event. 3. **Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)):** The firm did not follow its CAPA procedure. For example, CAPA (b)(