483
Mol Belting SystemsFDA 483 - Mol Belting Systems - October 29, 2024
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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.
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ID · 639fa507-0039-4595-a109-bf96328df50b