FDA 483 - American Spraytech LLC - April 11, 2024

American Spraytech LLC, a contract manufacturer in Branchburg, NJ, was inspected by the FDA, revealing significant deficiencies in its quality system. The inspection cited the firm for failing to adequately establish procedures for controlling nonconforming product during manufacturing. Additionally, the firm's corrective and preventive action system was found to be inadequate, lacking proper analysis of quality data and thorough investigation into the causes of nonconformities.