FDA 483 - Orange Lab Holdings - December 20, 2024

An FDA inspection of Orange Lab Holdings in Anaheim, CA, revealed eight significant deficiencies in their manufacturing of OTC drug and cosmetic products. The firm demonstrated a pervasive lack of fundamental CGMP controls, including an absent quality control unit, unvalidated processes, and inadequate data integrity measures. Several critical issues were repeat observations from a previous inspection, highlighting persistent non-compliance.