FDA warns Spectra Therapy for GMP violations, marketing unapproved device

The US Food and Drug Administration (FDA) has cited Spectra Therapy for ten violations of current good manufacturing practices (CGMP) for its LASERwrap system, including instituting a design change without proper procedures, failing to follow proper corrective and preventive actions, and failing to establish a system for quality audits.

Additionally, FDA said the device lacks proper approval, as it does not meet the criteria for marketing without submitting a premarket notification as an infrared lamp under 21 CFR 890.5500, and does not have an approved premarket approval (PMA) or investigational device exemption (IDE) for the device.

The company was cited for violations related to medical device reporting and for marketing products for conditions they were not authorized to treat. The site, located in Port Huron, MI, underwent a four-day inspection in September 2024.

The company produces therapeutic infrared heating lamps known as the LASERwrap system. This system includes the Spectra A-100 Impulse Laser Unit, along with accessories such as filament wraps and pads that are applied to the body and connected to the unit. The product is designed to alleviate pain and promote healing by enhancing circulation.

The firm was cited for not establishing and maintaining procedures to control the design of the device. This failure resulted in the inability to ensure that the specified design requirements were met, demonstrating that the design was developed in accordance with the design control requirements outlined in 21 CFR § 820.30(a) through § 820.30(j).

The letter states that “your untitled and undated design document provided during the inspection did not provide adequate detail or objective evidence to demonstrate how the specific specifications and operating modes listed in this document were developed, established, verified, and validated to ensure that device conforms to user needs and the proper functioning of the device. Further, your firm was unable to provide evidence that software validation and/or risk analysis were performed.”

Another problem was the firm’s failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR § 820.100. FDA said, “Your firm’s corrective and preventive procedure, BSP-05 Corrective and Preventative Actions Procedure, has not been implemented and remains in a draft status.”

The company also failed to establish procedures for quality audits to assure that the quality system complies with the established quality system requirements. The company has not conducted a quality audit since it started manufacturing these devices in 2008.
Investigators said the company failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.

FDA also noted that Spectra has a cleared 510(k) for the Spectra Therapy Spectra A1000 Laser Device but notes that there is evidence the LASERwrap device is marketed for different intended uses, including chronic pain, irritable bowel syndrome, and tendonitis. As such, FDA said the device is not exempt from premarket notification requirements and that the additional intended uses “constitute a major change or modification to the intended use of the device cleared under K080689, for which your firm lacks clearance or approval.”

The company was advised to address the noted violations and to explain how it plans to prevent these violations, within 15 days.

Warning letter

FDA warns Spectra Therapy for GMP violations, marketing unapproved device

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