FDA 483 - The Skin Atelier, Inc. - April 04, 2019

The FDA inspected The Skin Atelier, Inc. in Goshen, NY, an OTC drug product manufacturer, and found significant deficiencies across its operations. The firm failed to perform essential testing for active ingredient potency, lacked validated manufacturing processes and equipment, and did not conduct adequate stability studies for product expiration dates. These findings indicate a severe lack of adherence to Good Manufacturing Practices, posing potential risks to product quality and consumer safety.