FDA 483 - NIMBLEHEART, INC - June 27, 2025

NIMBLEHEART, INC in Sunnyvale, CA, a manufacturer of the Class 2 Physiotrace Smart System, was inspected by the FDA and received nine observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for design changes, corrective and preventive actions, complaint handling, management reviews, internal audits, product identification, non-conforming product control, supplier management, and equipment maintenance. These issues indicate a systemic failure to establish and maintain an effective quality system.