FDA 483 - Lutech Industries Inc - March 26, 2025

Ancora Industries Inc, a specification developer and importer of Class II Medical Devices in Ronkonkoma, NY, was cited for inadequate maintenance of records related to document changes. Specifically, the firm failed to create Engineering Change Requests for part number changes to printed circuit boards used in Digital Video Colposcopes, and the Bill of Materials did not reflect these changes or show evidence of approval. This indicates a significant deficiency in their document control and change management processes.