FDA 483 - The Skin Atelier, Inc. - July 26, 2024

The Skin Atelier, Inc., an OTC drug manufacturer in Goshen, NY, was cited for significant deficiencies in its quality control unit, particularly regarding oversight of contract operations and the absence of critical written procedures. The inspection revealed a lack of proper supplier qualification, inadequate stability data to support product expiration dates, and failures in managing and inspecting reserve samples. These issues indicate a systemic breakdown in quality management, with some observations being repeats from previous inspections.