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NDAL Mfg Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacture of finished pharmaceutical products, including nasal spray formulations containing manuka honey, which were also found to be unapproved new drugs. The company's quality control unit failed to exercise proper oversight to ensure drug products met established specifications for identity, strength, quality, and purity, and the firm lacked adequate procedures and a functional quality unit despite utilizing contract manufacturers and retaining responsibility for product release to market. The inspection, conducted from September 8-20, 2021, identified violations under 21 CFR parts 210 and 211, rendering the drug products adulterated and their introduction into interstate commerce prohibited.