Spectra Therapy, LLC

Warning LetterOpen

John J. Stephan President & CEO Spectra Therapy, LLC 3350 Lapeer Road Port Huron , MI 48060 United States johnstephan@spectratherapy.comFEI 3008539245Issued Jul 22, 2025Center for Devices and Radiological Health

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Violations21

Issue DateJul 22, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Spectra Therapy, LLC
Location: John J. Stephan President & CEO Spectra Therapy, LLC 3350 Lapeer Road Port Huron , MI 48060 United States johnstephan@spectratherapy.com
FEI Number: 3008539245
Country: United States
Issue Date: July 22, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

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.

Spectra Therapy, LLC FDA Warning Letter, July 22, 2025