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NuGeneration Technologies LLC was cited for significant Current Good Manufacturing Practice (CGMP) violations in its drug manufacturing facility in Emeryville, California during a September 2022 inspection. The company failed to conduct adequate release testing of its NuRinse Hand Sanitizer product prior to distribution, specifically not performing required strength and identity testing of the active ingredient (ethanol), impurity testing, and microbiological testing as mandated by 21 CFR 211.165(a). The firm's October 2022 response to the FDA's Form 483 was deemed inadequate for lacking sufficient detail and evidence of corrective actions necessary to achieve CGMP compliance.