Quality Blending, Inc – FDA 483, Jan 30, 2020

Quality Blending, Inc. in Anoka, MN, a veterinary and OTC drug manufacturer, was cited for significant deficiencies in its quality control unit during an FDA inspection. Observations included the release of out-of-specification finished products, inadequate testing of raw materials and active ingredients, incomplete batch records, and a lack of temperature monitoring and staff training procedures. Additionally, batch production records were found to be missing copies of product labeling.