FDA 483 - Akervall Technologies, Inc. - November 06, 2025

Akervall Technologies, Inc., a manufacturer in Saline, MI, was inspected by the FDA and received a Form 483 with 10 observations. The inspection revealed significant deficiencies across multiple quality system areas, primarily concerning the lack of adequately established and documented procedures for critical processes such as complaint handling, purchasing controls, equipment management, nonconforming product control, quality audits, training, in-process inspections, design changes, and Medical Device Reporting. These issues indicate a systemic failure to maintain a robust quality management system.