FDA EIR - Zoll Manufacturing Corporation - July 15, 2016

An FDA follow-up inspection of Zoll Manufacturing Corporation, a Pittsburgh-based medical device manufacturer of the Class 3 LifeVest wearable defibrillator, was conducted from July 12-15, 2016. This inspection aimed to verify corrective actions taken in response to a previous inspection on January 4, 2015, which identified significant regulatory issues under the Compliance Program for Medical Device Manufacturers (7382.845B). The prior inspection resulted in a seven-item FDA Form 483, citing deficiencies across several critical areas. These included inadequate submission of Medical Device Reports (MDRs) for serious incidents, insufficient review and investigation of product complaints, and a lack of established procedures for incoming product acceptance. Additionally, the company's risk analysis was deemed inadequate, corrective and preventive action activities were not properly documented, and the organizational structure failed to ensure device compliance with regulatory standards (21 CFR 820). During the 2016 follow-up, the FDA reviewed the company’s management, design, production, process, and corrective and preventive action controls. Zoll Manufacturing demonstrated comprehensive efforts to resolve the previously identified violations. Key improvements included implementing a standardized reportability decision-making process for MDRs, developing cause-and-effect diagrams for trending complaints, and establishing a robust procedure for complaint receipt and evaluation. Management also confirmed enhancements in incident report investigation, objective evidence documentation, and statistical data analysis. As a result of these documented corrective actions and observed improvements, no FDA Form 483 was issued, and the inspection was classified as "No Action Indicated".