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

The FDA issued a warning letter to the company located at 3350 Lapeer Road, Port Huron, MI, following an inspection from September 10-13, 2024. The firm manufactures therapeutic heating infrared lamps, marketed as the LASERwrap system, which includes the Spectra A-100 Impulse Laser Unit and accessories. These products are classified as medical devices under the Federal Food, Drug, and Cosmetic Act.

The inspection revealed significant violations of the Quality System Regulation, specifically under 21 CFR Part 820. Key issues included the failure to establish and maintain adequate design control procedures, as required by 21 CFR § 820.30. The company lacked detailed procedures to ensure the design specifications were met and failed to verify or validate design changes, such as those made to the A-100 Impulse Laser unit housing.

Additionally, the firm did not have procedures to manage nonconforming products, as required by 21 CFR § 820.90. Nonconforming lasers were inadequately documented and managed, with no formal investigation or documentation process in place.

The company also failed to implement corrective and preventive action procedures, as outlined in 21 CFR § 820.100, and did not maintain adequate records of investigations, violating 21 CFR § 820.198(e). Furthermore, the firm did not properly evaluate and select suppliers based on their ability to meet quality requirements, as required by 21 CFR § 820.50(a)(1).

The FDA deemed the firm"s response to these violations inadequate and requested a comprehensive corrective action plan, including the establishment of design control procedures, documentation of nonconformance management, and implementation of a corrective and preventive action procedure. The firm must also provide a timeline for these actions and ensure compliance with regulatory requirements.