FDA 483 - Bio-Thera Solutions, Ltd. - January 17, 2025

An FDA inspection of Cosmetic Specialty Labs, Inc., a cosmetic manufacturer producing Over-the-Counter (OTC) drug products, was conducted from January 29 to February 8, 2024. The inspection revealed several significant deficiencies, many of which were repeat observations from a 2017 inspection, indicating a systemic lack of adherence to regulatory requirements.