FDA 483 - The W.S. Badger Company, Inc. - September 14, 2021

The W.S. Badger Company, Inc. in Gilsum, NH, was inspected regarding its manufacturing of OTC drug products. The inspection revealed significant deficiencies in process validation, quality control unit oversight, investigation of discrepancies, equipment cleaning validation, stability programs, and annual product reviews. Several observations were repeats from a previous inspection, indicating persistent issues with quality systems and compliance.