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Talk to a SpecialistTalk to a SpecialistClean Solutions LLC, a drug manufacturer in New Jersey, was found to have violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their over-the-counter topical products (such as antibacterial hand soaps containing benzalkonium chloride) adulterated. Specific violations included failing to conduct identity testing on each component lot and failing to validate and establish the reliability of component suppliers' test analyses at appropriate intervals, relying instead on suppliers' certificates of analysis without verification. The company's May 2024 response to FDA's Form 483 was deemed inadequate because it lacked supporting documentation and sufficient evidence of corrective actions needed to achieve CGMP compliance. These deficiencies meant the firm had no scientific evidence that components conformed to appropriate specifications before being used in drug product manufacturing.