FDA 483 - Paragon Manufacturing Corp. - September 11, 2019

Paragon Manufacturing Corp., a contract manufacturer in Everett, WA, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately establish and implement procedures for incoming product acceptance, control of nonconforming product, corrective and preventive actions, equipment calibration, supplier agreements, purchased product conformity, and document control. These issues indicate significant gaps in the firm's quality management system.