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Talk to a SpecialistTalk to a SpecialistYangzhou Yulou Paper Products Co., Ltd., a manufacturer of over-the-counter sterile drug products, failed to establish and follow appropriate written procedures to prevent microbiological contamination and did not validate aseptic and sterilization processes as required by Current Good Manufacturing Practice regulations. The company also failed to establish adequate laboratory controls with scientifically sound specifications to ensure drug product identity, strength, quality, and purity. These significant compliance failures rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act, following FDA's review of records submitted in response to an inspection request issued in February 2025.