FDA 483 - Detectamet, Inc. - July 11, 2019

Betamet, Inc., an initial importer, repackager, and relabeler in Richmond, VA, received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for complaint handling, device history records, corrective and preventive actions, and supplier controls. These issues indicate a lack of fundamental controls for ensuring product quality and compliance.