FDA 483 - Hard Manufacturing Co., Inc. - March 06, 2025

Hard Manufacturing Co., Inc. in Buffalo, NY, a medical device manufacturer, received a Form 483 with five observations. The inspection revealed significant deficiencies in process validation for welding and lathing, lack of documented in-process inspections, and inadequate corrective and preventive action procedures. Additionally, process control procedures for welding and software validation for production equipment were not established or adequately performed.