FDA 483 - NuEra Nutraceutical Inc - February 18, 2022

NuEra Nutraceutical Inc. in Richmond, Canada, was inspected by the FDA regarding its dietary supplement manufacturing. The inspection revealed significant deficiencies in quality control, including a failure to establish proper specifications for components and finished products, and inadequate testing methods. Additionally, the facility exhibited poor pest control with evidence of rodent infestation in storage areas.