FDA 483 - Keller Laboratories - April 06, 2026

National Dentex LLC, dba NDX Keller, a medical device manufacturer in Fenton, MO, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in their quality management system, including a lack of a risk-based approach, failure to include Unique Device Identifiers on device labeling, and inadequate maintenance of design and development files for medical devices. These issues indicate a moderate level of non-compliance with medical device regulations.