FDA 483 - Aracely Express, Inc - November 20, 2023

Aracely Express, Inc., a warehouse distributor of dietary supplements in Houston, TX, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to establish and follow written procedures for critical operations including holding, distribution, product complaints, returned products, and pest control. Additionally, the inspection revealed a lack of reserve samples and inadequate environmental controls in the warehouse, indicating a systemic failure in quality management.