FDA 483 - Northwest Cosmetic Laboratories LLC (DBA Elevation Labs Idaho) - February 24, 2020

Northwest Cosmetic Laboratories LLC (DBA Elevation Labs Idaho) was inspected regarding its drug manufacturing operations. The inspection revealed significant deficiencies in process validation for SPF drug products and inadequate testing and release procedures, including the release of products without finalized specifications or scientific rationale for conformance. These issues indicate a failure to ensure product quality and compliance with regulatory standards.