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AQ USA Inc., d.b.a Ross Healthcare Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of drug products at its Lynden, Washington facility, which produces the same product line previously made at a Canadian facility already on Import Alert due to substantial CGMP violations. The company failed to conduct appropriate laboratory testing for each batch to ensure freedom from objectionable microorganisms and failed to establish adequate laboratory controls with scientifically sound specifications, standards, sampling plans, and test procedures for components, containers, closures, and finished drug products. These manufacturing deficiencies rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.