FDA 483 - Accusync Medical Research Corp - August 15, 2019

Water-Jel Technologies, LLC, a manufacturer of pharmaceuticals and medical devices in Carlstadt, NJ, was cited for 11 observations during an FDA inspection. The findings highlight significant deficiencies across its quality system, including inadequate investigations into discrepancies, ineffective corrective and preventive actions, and poor control over design changes and production processes. The firm also failed to maintain proper device master records and ensure adequate acceptance activities for components.