FDA 483 - Medspira, Llc - January 16, 2024

Medspira, Llc received a Form 483 citing significant quality system deficiencies, primarily impacting the design and post-market surveillance of their Petite Catheter. The firm failed to adequately verify and validate design changes, maintain updated risk analyses despite numerous complaints, and establish effective procedures for corrective actions, nonconforming product control, and medical device reporting. These systemic issues led to the release of devices with known defects, including inflation/deflation problems and balloon ruptures, posing potential risks to patients.