FDA 483 - Norwich Pharmaceuticals, Inc. - March 16, 2021

An FDA inspection of Norwich Pharmaceuticals, Inc. in Norwich, NY, identified significant deficiencies related to equipment cleaning procedures and equipment qualification. The firm lacked detailed cleaning instructions, proper cleaning verification, and formal cleaning validation, and failed to adequately qualify critical manufacturing and checkweighing equipment for its intended commercial use. These observations indicate a need for improved adherence to Good Manufacturing Practices.