FDA WARNING_LETTER - ZOLL Medical Corporation - March 18, 2011

On April 22, 2011, the FDA issued a Warning Letter to ZOLL Medical Corporation following an inspection from January 24 to March 18, 2011, at their Chelmsford, MA facility. The inspection revealed that ZOLL's cardiac resuscitation products, including AEDs and E Series defibrillators, were 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).

Key violations included: 1. **Failure to identify all actions needed to correct and prevent recurrence of nonconforming product (21 CFR 820.100(a)(3))**: Corrective and Preventive Action (CAPA) 2009-026, opened for battery life cycle validation issues, failed to assess the impact of "passivation" on battery life calculation despite 15 complaints of premature battery depletion. The firm's submitted "AED Battery Life Calculation" memo was inadequate, lacking formulas, data references, test methods, and addressing passivation. A "AED Plus Standby Battery Life Validation" document was also inadequate, assuming a 5-year lifecycle without statistically valid data or addressing passivation. ZOLL also failed to implement the "AED Plus Post Market Life Cycle Test Plan" identified in CAP