The U.S. Food and Drug Administration (FDA) has issued a warning letter to Spectra Therapy citing ten violations of current good manufacturing practices (CGMP) related to its LASERwrap system. The violations include implementing a design change without proper procedures, failing to follow corrective and preventive action protocols, and not establishing a system for quality audits.
The FDA also determined that the LASERwrap device lacks appropriate market clearance. It does not meet the criteria for marketing as an infrared lamp under 21 CFR 890.5500 without premarket notification and does not have an approved premarket approval (PMA) or investigational device exemption (IDE).
The inspection, which took place in September 2024 at the company’s Port Huron, Michigan facility, found multiple deficiencies in compliance. The LASERwrap system, including the Spectra A-100 Impulse Laser Unit and its accessories, is marketed as a therapeutic infrared heating lamp intended to relieve pain and promote healing by improving circulation.
According to the FDA, Spectra Therapy failed to establish and maintain design control procedures required under 21 CFR § 820.30. The documentation provided by the company lacked sufficient detail and objective evidence to confirm that device specifications and operating modes were developed, verified, and validated to ensure proper functioning. The agency also noted that the firm could not provide proof of software validation or a risk analysis.
The inspection further revealed that Spectra Therapy had not implemented its draft corrective and preventive action procedure, BSP-05, as required by 21 CFR § 820.100. Additionally, the company had not performed any quality audits since beginning manufacturing operations in 2008, failing to ensure compliance with quality system requirements.
Medical Device Reporting (MDR) procedures were also found lacking. The company did not maintain adequate written MDR procedures as required under 21 CFR 803.17.
While Spectra Therapy holds a cleared 510(k) for the Spectra Therapy Spectra A1000 Laser Device, the FDA found evidence that the LASERwrap device was marketed for unapproved uses, including chronic pain, irritable bowel syndrome, and tendonitis. Such expanded indications constitute a major modification to the cleared device and require new premarket clearance or approval.
The FDA instructed the company to respond within 15 days outlining the steps it will take to correct the violations and prevent recurrence. Failure to adequately address these issues could result in enforcement actions, including product seizure, injunction, or civil penalties.
This case underscores the FDA’s increased scrutiny of medical device manufacturers’ quality systems and marketing practices. Companies must ensure that design controls, quality audits, and intended use claims meet regulatory requirements before products reach the market.
At EMMA International, we help medical device manufacturers navigate the complexities of FDA compliance, from establishing robust quality management systems to ensuring marketing claims align with approved indications. Our team works with clients to address regulatory gaps before they become enforcement issues, helping them maintain both compliance and market credibility. This proactive approach can safeguard companies against the significant operational and reputational impacts of warning letters and recalls.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more.
References
U.S. Food and Drug Administration, Warning Letter to Spectra Therapy, 2025
