OraLabs LLC – FDA 483, Jan 10, 2020

An FDA inspection of OraLabs, Incorporated in Parker, CO, a manufacturer of drug products, revealed significant deficiencies across multiple systems. The firm failed to establish adequate laboratory controls, maintain equipment and facilities in a sanitary and good state of repair, and prevent contamination. Additionally, the quality control unit did not fully adhere to its responsibilities, leading to issues with CAPA implementation and inadequate investigations.