FDA 483 - Spectra Therapy, LLC. - September 13, 2024

An FDA inspection of Spectra Therapy, LLC. in Port Huron, MI, a medical device manufacturer, revealed six significant deficiencies in its quality system. The firm has failed to establish fundamental procedures for design control, corrective and preventive actions, finished device acceptance, quality audits, management review, and document control. The lack of design control procedures is a repeat observation from a prior inspection, indicating persistent non-compliance.