FDA 483 - Exer Labs, Inc. - October 24, 2024

An FDA inspection of Exer Labs, Inc. conducted from October 17 to October 24, 2024, identified ten significant observations related to the company's quality system. The primary issues centered on the absence of established and documented procedures and records across critical operational areas, indicating non-compliance with quality system requirements for medical device manufacturers under the Federal Food, Drug, and Cosmetic Act. Key violations included a complete lack of documented procedures for design control, including design changes, and the absence of a Design History File for their Exer Scan product. The company also failed to establish adequate procedures and records for corrective and preventive actions (CAPA), handling customer complaints, and medical device reporting (MDR). Further deficiencies involved the absence of documented installation instructions, management review processes, and the appointment of a management representative. Crucially, the inspection found no established procedures or records for quality audits, employee training, or purchasing controls and supplier qualification. Exer Labs, Inc.'s Chief Technology Officer reportedly committed to correcting all identified observations. These required actions necessitate the development, documentation, and implementation of a comprehensive quality system to ensure compliance with regulatory standards for medical device manufacturing.