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Verde Cosmetic Labs LLC manufactured OTC topical drug products (sunscreens, pain relief, and acne treatments) in violation of Current Good Manufacturing Practice regulations for finished pharmaceuticals. The FDA's September-October 2021 inspection identified critical failures in the company's quality control unit, including inadequate microbiological testing prior to product release, insufficient investigation of out-of-specification results, failure to document and assess manufacturing changes, lack of an adequate stability program, and failure to conduct annual product reviews. These control deficiencies rendered the company's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.