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Nephron SC Inc., a pharmaceutical manufacturer, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished drug products, rendering their drugs adulterated. During a March-April 2022 inspection, the FDA identified critical violations including failure to thoroughly investigate unexplained discrepancies or specification failures in batches of sterile injectable products (Sterile Water for Injection, Ketorolac Tromethamine Injection, and Sodium Chloride Injection), inadequate investigations for both terminal sterilization and aseptic processing products, and failure to submit a required NDA Field Alert Report to the FDA within three working days of discovering significant changes or deterioration in distributed drug products.