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Talk to a SpecialistTalk to a SpecialistOrean Personal Care Ltd., a drug manufacturer in the United Kingdom, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter pharmaceutical products. The FDA inspection revealed that the company failed to adequately test incoming components, including active pharmaceutical ingredients, for identity and conformity with written specifications, and instead relied solely on supplier certificates of analysis without validating their reliability. These deficiencies meant the company lacked scientific evidence that components met required specifications before use in manufacturing, rendering the drug products adulterated. The violations were documented during a March 2024 inspection, with the company's April response acknowledged but found insufficient to address the fundamental quality control failures.