FDA 483 - Ceragroup Industries Inc - April 15, 2025

Ceragroup Industries Inc., a medical device manufacturer in Fort Lauderdale, FL, was cited with two observations during an FDA inspection. The firm failed to adequately establish and follow procedures for corrective and preventive actions, with multiple CAPAs remaining open without verification or validation. Additionally, the firm's purchasing controls were found deficient, as it accepted raw materials for its Class II medical devices without required Certificates of Conformance or Analysis.