FDA 483 - Mol Belting Systems - October 29, 2024

An FDA inspection of Belt Power LLC in Grand Rapids, MI, a drug packager and labeler, revealed significant deficiencies in its quality control unit and adherence to current good manufacturing practices. Observations included a lack of written procedures for quality control, employee training, stability programs, and master production records. The firm also failed to establish specifications and controls for laboratory testing and labeling.