FDA 483 - Raining Rose, Inc. - January 24, 2020

An FDA inspection of Raining Rose Inc, an OTC drug manufacturer in Cedar Rapids, IA, revealed significant deficiencies in quality control. The firm failed to perform identity testing on drug product components, lacked restricted access to labeling materials, and did not adequately clean manufacturing equipment and utensils. These issues indicate a lack of control over product safety, identity, strength, quality, and purity.