FDA 483 - Colorlab Cosmetics, Inc. - January 06, 2022

An FDA inspection of Colorlab Cosmetics, Inc. in Williston, VT, revealed 18 significant deficiencies in their manufacturing operations for Sunscreen Lip Gloss. The firm lacks a functional quality control unit, proper testing and release procedures for drug products, and adequate controls over equipment, facilities, and personnel training, indicating a systemic failure to adhere to Good Manufacturing Practices.