Micro Stamping Corp – FDA 483, Jan 18, 2023

Micro Stamping Corp, a medical device manufacturer in Somerset, NJ, received a Form FDA 483 with five observations. The inspection revealed significant deficiencies in quality system procedures, including inadequate corrective and preventive actions, environmental controls, rework processes, supplier management, and document control. These issues led to concerns such as the use of uncalibrated gages and lack of microbiological control in a cleanroom.