FDA 483 - Washington Homeopathic Products, Inc. - August 19, 2021

Washington Homeopathic Products, Inc. in Berkeley Springs, WV, was cited for significant quality control and manufacturing deficiencies during an FDA inspection. The firm failed to conduct a timely risk assessment and recall determination for homeopathic drug products made with raw materials that failed identity testing. Additionally, the inspection revealed inadequate written procedures for production and process controls, including deficient process validation studies, and a failure to follow their written stability testing program.