FDA 483 - Needletech Products, Inc - October 08, 2021

Needletech Products, Inc. in North Attleboro, MA, a contract manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed inadequate procedures for corrective and preventive actions, as well as insufficient process control procedures, particularly concerning preventive and unscheduled maintenance. These issues indicate a moderate level of non-compliance with quality system regulations.