483
Neosoma, Inc.FDA 483 - Neosoma, Inc. - February 21, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
- Person
Open in Dashboard
ID · cd8be919-152e-455c-b3ca-40d4161f4358