FDA 483 - CFS Dental, Inc - October 31, 2023

During an FDA inspection conducted from October 30-31, 2023, CFS Dental, Inc., a manufacturer based in Hialeah, FL, received a Form FDA 483. This document, issued to President Angel Fernandez, detailed observations indicating potential deviations from regulatory requirements. The primary issue identified was a lapse in supplier control. The inspection revealed that the company had not adequately evaluated its potential suppliers and contractors. Specifically, despite CFS Dental, Inc.'s own purchasing procedure (SOP 7.4) requiring a Quality Agreement for each manufacturer or assembler, no such agreement was established with its sole supplier for resin. This observation highlights a failure to ensure that suppliers meet specified quality requirements. Issued pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, the FDA 483 is a formal notification of these observations. While not a final determination of compliance, it necessitates that CFS Dental, Inc. implement prompt corrective actions to address the identified deficiencies and ensure adherence to quality system regulations. The company reportedly "Promised to correct" the noted observation.