FDA 483 - Front Door Pharmacy, LLC dba Pure Pharmacy (Pure Pharmaceuticals) - June 07, 2021

An FDA inspection of Front Door Pharmacy, LLC dba Pure Pharmacy in Houston, TX, revealed critical deficiencies in aseptic processing and environmental controls. The firm failed to maintain adequate first-pass air, conduct proper media fills, and implement a viable environmental monitoring program. Additionally, issues included unvalidated sporicidal agents, poor cleanroom air quality, and inadequate handling of hazardous drugs, indicating significant risks to product quality and patient safety.