FDA WARNING_LETTER - Defibtech, LLC - August 18, 2010

Defibtech, LLC received an FDA Warning Letter on September 22, 2010, following an inspection from July 29 to August 18, 2010, at their Guilford, CT facility. The inspection found that the firm's automated external defibrillators (AEDs) are adulterated, as their manufacturing controls do not conform to the Quality System (QS) regulation (21 CFR Part 820). Two primary violations were identified: 1) Failure to establish and maintain adequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)(3)). This was highlighted by the firm's delayed recall of DBP battery packs despite known nonconformance issues. 2) Failure to document the evaluation and investigation of nonconforming product and adequately control such products (21 CFR 820.90(a)). Nonconforming Material Reports for Sentry DDU-100 AEDs were incomplete, lacking investigation details and product dispositions. The FDA reviewed Defibtech's September 3, 2010, response but found some proposed corrective actions, particularly the timeline for addressing open Nonconforming Material Reports, inadequate. The firm is required to promptly correct all violations, provide a comprehensive plan to prevent recurrence, and submit documentation of corrective actions. Additionally, Defibtech must arrange for an audit by an outside expert consultant of its quality systems and provide certifications. Non-compliance could lead to regulatory actions such as seizure, injunction, civil money penalties, and impact on device approvals and government contracts. The letter also reminded the firm of its obligation to report device corrections or removals that reduce a health risk.