FDA EIR - Zoll Lifecor Corporation - March 11, 2010

An FDA inspection of Zoll Lifecor Corporation, a manufacturer of the Class III LifeVest wearable automatic defibrillator, was conducted from March 9-11, 2010. This routine Level II Quality System Inspection Technique (QSIT) aimed to assess compliance with medical device regulations, specifically according to CP 7382.845. The inspection encompassed management controls, design controls, corrective and preventive action (CAPA), and production and process controls.

The inspection concluded with no significant objectionable conditions, indicating a high level of compliance. A minor weakness was identified concerning the firm's documentation and tracking practices for engineering responses to complaint investigations, noting a lack of standardized format despite consistent documentation of high-frequency events. Management acknowledged this observation and expressed intentions to implement improvements.

Consequently, no FDA 483 (Inspectional Observations) was issued. Discussions also included Zoll Lifecor's planned facility relocation, with the FDA finding the company's preliminary plans for addressing regulatory obligations, such as site-change supplements and process re-validation, to be reasonable. The FDA advised further consultation with the Center for Devices and Radiological Health (CDRH/OC) for specific guidance on these requirements.