FDA 483 - The W.S. Badger Company, Inc. - June 01, 2023

The W.S. Badger Company, Inc. in Gilsum, NH, a drug manufacturer, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight a systemic failure to thoroughly investigate discrepancies, establish adequate microbiological controls, maintain proper documentation, and validate critical laboratory methods and equipment. Many of these issues are repeat observations from previous inspections, indicating persistent non-compliance.