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Talk to a SpecialistTalk to a SpecialistQuality CDMO, Inc. was cited for manufacturing and distributing unapproved new drug products, including Sodium Sulfacetamide 10% Wash, Sodium Sulfacetamide 10% and Sulfur 5% Cleanser, Selenium Sulfide 2.25% Shampoo, Urea 40% Cream, and Salicylic Acid 5.9% Topical Cream, in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The FDA's June 2023 inspection and subsequent review of the company's website revealed that these products lacked required new drug applications (NDAs) despite being marketed with therapeutic claims for treating conditions such as seborrheic dermatitis and other dermatological indications. The violations were identified based on labeling evidence collected at the facility and submissions to the Drug Registration and Listing System that demonstrated the products' intended uses as drugs.