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Fresh Farms LLC, a drug manufacturer in Las Vegas, Nevada, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter hand sanitizer products during an FDA inspection in November 2021. The company failed to establish an adequate quality unit with documented responsibilities and procedures for quality control oversight, and did not ensure that product specifications were established, approved, and properly followed. Fresh Farms' response to the FDA's inspection findings was deemed inadequate because it lacked supporting documentation and evidence of corrective actions, while also making claims about CGMP compliance that contradicted statements made during the inspection itself.