FDA WARNING_LETTER - Zoll Lifecor Corporation - June 20, 2014

On September 23, 2014, the FDA issued a Warning Letter to Zoll Manufacturing Corporation (formerly Zoll Lifecor Corporation) following an inspection from May 22, 2014, to June 20, 2014. The inspection revealed that the firm's Class III medical device, the Life Vest, was 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 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations included: 1. **Failure to document CAPA results (21 CFR 820.100(b))**: Specifically, no documented CAPA activities for inappropriate shock treatments due to noise/vibration, issues with use by patients with cognitive/physical limitations, or bystander interference. 2. **Failure to investigate complaints (21 CFR 820.198(a))**: Inadequate investigation and evaluation of complaints suggesting the Life Vest may have caused or contributed to death or serious injury. The firm's response was deemed inadequate for