FDA WARNING_LETTER - Cardiac Science Corporation - October 01, 2009

An FDA inspection of Cardiac Science Corp. (Bothell, Washington) from September 1 to October 1, 2009, revealed that their Automatic External Defibrillators (AEDs) and cardiac stress testing equipment are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). The firm's October 16, 2009, response to the FDA 483 was deemed inadequate for several violations.

Key violations include: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a)(3))**: The firm failed to identify and implement corrective actions for distributed Powerheart AEDs with suspect resistors (CAPA CA-815) and relays (CAPA CA-922), which could lead to therapy delivery failures. Software updates were deemed insufficient as they only detect, not prevent, failures. An earlier CAPA (CA-698) for "service required" prompts, attributed to a capacitor issue, was closed prematurely as subsequent complaints indicated recurrence. 2. **Failure to review and evaluate complaints and document investigations (21 CFR 820.198(b))**: The firm did not document failure