Paragon Manufacturing of Everett, Washington lacked proper procedures for acceptance of incoming products and for nonconforming products, an FDA inspection revealed.

The contract manufacturer also failed to follow procedures that require corrective actions to be completed without delay to prevent recurrence of the nonconformities. Action forms were completed in October 2018 for at least three product failures, but a root cause investigation, corrective action and verification were not completed by the time of the FDA’s inspection in September 9, 2019.

FDA investigators observed that the facility’s equipment was not routinely calibrated, and document control procedures were also found to be lax.