FDA 483 - Precision Forms, Inc. - May 01, 2025

An FDA inspection of Precision Forms, Inc. in Butler, NJ, a manufacturer of medical devices, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for monitoring and controlling validated cleaning processes, properly validate processes under worst-case conditions, and implement effective corrective and preventive actions through robust quality data analysis. These issues indicate a lack of control over critical manufacturing processes and quality management.