FDA 483 - Purechempros LLC - November 22, 2022

Purechempros LLC, a non-sterile drug manufacturer in Tempe, AZ, was inspected by the FDA from November 17-22, 2022, revealing significant deficiencies across its quality, laboratory, production, and facilities systems. The firm lacks fundamental controls for manufacturing Liquid Hand Sanitizer and Food Grade Hydrogen Peroxide, including the absence of a quality control unit and inadequate laboratory testing. Key issues also include unvalidated processes, insufficient stability testing, and poor equipment maintenance and cleaning records.