FDA 483 - SnugZ USA, Inc. - September 17, 2021

An FDA inspection of SnugZ USA, Inc. in West Jordan, UT, an OTC drug manufacturer, revealed numerous significant deficiencies across its manufacturing and quality control operations. The firm failed to establish adequate laboratory controls, process validation, complaint handling, and environmental monitoring, indicating a systemic lack of adherence to good manufacturing practices. These issues raise concerns about the identity, strength, quality, and purity of their SPF Lip Balm, SPF Sunscreen, and Hand Sanitizer OTC products.