FDA 483 - Choice Spine LLC - September 30, 2019

Choice Spine LLC, a human tissue distributor in Knoxville, TN, received an FDA Form 483 for failing to perform and document corrective actions. The firm did not address or investigate a malfunctioning freezer temperature probe, which resulted in a two-week period where proper storage conditions for distributed product could not be accurately monitored. This lapse indicates a failure in maintaining adequate quality control over product storage.