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Creative Essences, Inc., a manufacturer of over-the-counter drugs for oral, nasal, rectal, and topical use, failed to comply with Current Good Manufacturing Practice (CGMP) regulations, rendering their drug products adulterated. During a March 2025 inspection, the FDA identified that the company's quality unit failed to thoroughly investigate unexplained discrepancies and batch failures that did not meet specifications, violating 21 CFR 211.192. Additionally, the company manufactured an unapproved new drug product that was introduced into interstate commerce in violation of FDA approval requirements and was misbranded under federal law.