FDA 483 - G. C. Hanford Manufacturing Co - June 17, 2022

An FDA inspection of G. C. Hanford Manufacturing Co in Syracuse, NY, a contract manufacturing operation, revealed significant deficiencies in quality control unit procedures, equipment design for aseptic processing, and process validation. The firm failed to complete customer complaint and variance investigations within established timeframes, did not assure unidirectional airflow in aseptic areas after an Air Handling Unit replacement, and lacked proper process validation after a major tablet press upgrade, resulting in product yield issues.