FDA 483 - Gussyup LLC - February 20, 2025

Gussyup LLC (dba Private Label Grooming) in Henderson, NV, an OTC drug manufacturer, was cited for significant deficiencies in its quality control and manufacturing processes during an FDA inspection. Observations included a lack of product testing, unvalidated expiration dates, missing written procedures for critical operations, and inadequate testing of raw materials and purified water. The findings indicate a systemic failure to ensure drug product quality, purity, and strength.