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Laboratorio Pharma International SRL, an over-the-counter drug manufacturer in Honduras, violated current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products that failed to meet appropriate standards of identity, strength, quality, and purity. The facility specifically failed to establish adequate laboratory controls including scientifically sound specifications, standards, sampling plans, and test procedures for components, containers, closures, and finished products. Additionally, the company's product GELAZUL Topical Analgesic was distributed as an unapproved new drug and was misbranded in violation of federal law, making its introduction into interstate commerce prohibited.