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Talk to a SpecialistTalk to a SpecialistPrime Lab LLC, a drug manufacturer in Puerto Rico, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter antibacterial hand soap and hand sanitizer products. The company failed to adequately test incoming raw material components for identity, purity, strength, and quality, and instead relied on suppliers' certificates of analysis without validating the reliability of those suppliers' testing at appropriate intervals. These deficiencies rendered the finished drug products adulterated under federal law, as the firm could not provide scientific evidence that components conformed to appropriate specifications prior to manufacturing.