FDA 483 - Hard Manufacturing Co., Inc. - February 24, 2022

Hard Manufacturing Co., Inc. in Buffalo, NY, a medical device manufacturer, was inspected and received a Form FDA-483 with seven observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate process validation, ineffective corrective and preventive actions, missing process control procedures, and unvalidated production software. These issues indicate a broad lack of adherence to established quality system requirements for medical device manufacturing.