The Flower Remedy – FDA 483, Jun 12, 2026

The Flower Remedy, a drug manufacturer in Englewood, CO, was inspected and received a Form 483 with six observations detailing significant deficiencies. The inspection revealed a pervasive lack of essential standard operating procedures, inadequate material controls, unvalidated production processes, and incomplete batch records. These findings indicate a broad failure to adhere to current Good Manufacturing Practice (cGMP) requirements across multiple operational areas.