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Spectra Therapy, LLC was warned for manufacturing the LASERwrap system (therapeutic infrared heating lamps) in violation of FDA's Quality System Regulation (21 CFR Part 820), making the devices adulterated. An FDA inspection conducted September 10-13, 2024 at the Port Huron, Michigan facility identified failures to establish and maintain design control procedures required under 21 CFR § 820.30(a)-(j) to ensure specified design requirements were met. The company submitted a response to the inspectional observations on the FDA 483 form, but the violations remained unresolved.