Jeni Lamb Rogers, BRANDED: Supplier qualification
Jeni Lamb Rogers, associate general counsel, BRANDED: As we enter 2022, supplier qualification and FDA compliance, as businesses continue to operate within the COVID environment, are top of mind for me. Although remote inspection and audits have become a significant and important tool to monitor supply chain compliance, there still has been less activity and opportunity for companies to monitor their suppliers with the same consistency that they could before COVID.
Moreover, with the reduced number of FDA inspections occurring and continued focus on mission critical inspection, there simply is less information available to inform regulatory diligence assessments. I will be watching closely how the agency enforces the dietary supplement CGMP and the Preventive Controls Rules against own label distributors and contract manufacturers, and how the agency responds to continued challenges in auditing and inspecting food facilities.