RESET TECHNOLOGY CORPORATION – FDA 483, Nov 26, 2019

During an FDA inspection conducted from November 14 to November 26, 2019, Anderson & Associates, LLC, a medical device manufacturer, received a Form FDA 483 citing numerous significant deficiencies in their quality management system for their Class II powered wheelchairs. Key violations, repeatedly identified in some instances, included an inadequate Corrective and Preventive Action (CAPA) system, with no CAPAs initiated despite multiple customer complaints. The company's complaint handling procedures were also found to be deficient, lacking uniform processing and documentation. Furthermore, the firm failed to validate an automated in-process testing software and demonstrated inadequate design validation, particularly regarding testing in actual use environments and risk analysis. Significant issues were noted with design change controls, as modifications to the powered wheelchair were made without proper documentation, verification, or approval. Additional observations highlighted a lack of procedures for production and process changes, insufficient purchasing controls (no supplier evaluations), and compromised internal quality audits due to a lack of auditor independence. The firm had also not conducted required management reviews. Nonconforming product procedures were inadequate, especially concerning rework documentation. Crucially, Anderson & Associates, LLC lacked a complete Device Master Record and maintained incomplete Device History Records for their powered wheelchair. The overall quality plan, as defined in their Quality Manual, was also deemed insufficient. These observations indicate a systemic lack of adherence to the regulatory framework outlined in 21 CFR Part 820, the Quality System Regulation. The company is required to address these deficiencies by implementing comprehensive corrective actions to ensure compliance and patient safety.