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RemedyRepack, Inc., a drug manufacturer, was found to have violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection in November 2022. The company failed to establish adequate written procedures for cleaning and maintenance of manufacturing equipment used in blister card and liquid repacking operations, and lacked chemical testing to confirm that cleaning procedures effectively removed product residues and cleaning agents. Quality control checks failed to identify contaminated equipment surfaces, and the company had multiple instances of visibly contaminated tablets and capsules, as well as insufficient data to support clean hold times for stored equipment. The company's corrective action response was deemed inadequate because it failed to provide scientific evidence demonstrating that interim cleaning procedures would resolve the violations.