FDA 483 - INDUCTION THERAPIES LLC - October 18, 2024

An FDA inspection of INDUCTION THERAPIES LLC in Louisville, KY, a drug labeler, revealed significant deficiencies across eight observations. The firm failed to establish and follow adequate written procedures for quality control, contract manufacturing oversight, batch recordkeeping, labeling, and employee training. These issues indicate a lack of control over drug product quality, identity, strength, and purity.