FDA 483 - Medspira, Llc - June 27, 2025

Medspira, LLC, a medical device manufacturer in Minneapolis, MN, was inspected by the FDA and received a Form 483 with six observations, many of which were repeat findings. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning corrective and preventive actions, non-conforming product control, complaint handling, design change, design risk analysis documentation, and document control. These issues indicate a systemic failure to adequately establish and implement critical procedures for ensuring product quality and safety.