FDA 483 - Aesthetic Plus Company Limited - September 15, 2023

An FDA inspection of Aesthetic Plus Company Limited, an OTC drug manufacturer in Sam Phran, Thailand, revealed significant deficiencies in their manufacturing and quality control processes. The firm failed to validate manufacturing and cleaning processes, qualify equipment, perform essential raw material and finished product testing, and conduct annual product reviews. These issues indicate a lack of adequate controls to ensure the identity, strength, purity, and quality of their OTC drug products distributed in the U.S.