FDA 483 - Neosoma, Inc. - February 21, 2025

An FDA inspection of Neosoma, Inc. in Groton, MA, a manufacturer of medical device software, revealed significant deficiencies in their quality system. The firm failed to maintain required device master and device history records for their Neosoma HGG image processing software. Additionally, procedures for the review and disposition of nonconforming products were inadequate, with investigations not being documented as required.