Failing to evaluate potential suppliers and making claims that its therapeutic massagers can help reduce cellulite and wrinkles have helped earn A-1 Engineering an FDA warning letter.
The Nov. 19 warning letter follows a March 2 to 18 inspection of the company’s Rancho Cucamonga, Calif., facility, during which FDA officials determined the company had failed to maintain device master records and history records.
In addition, it had not maintained schedules for adjustment and cleaning of equipment or established quality system procedures.
The company — which makes the Neurotris SX-Series Machines and Neurotris PICO Toner therapeutic massagers — also is dinged for not evaluating and keeping documentation on component and parts suppliers.
In addition, the company did not maintain complaint files or schedules for the adjustment, cleaning and other maintenance of equipment.
Further, while the company told the inspector that its devices are exempt from premarket notification, the agency has reached a different conclusion.
The letter points out that the therapeutic massagers generally are intended to relieve minor muscle aches and pains, but the company is marketing them for uses such as wrinkle reduction, face lifting, neck tightening, cellulite reduction and muscle toning.
“To date, we have not received a response from you concerning our investigator’s observations,” the letter states, adding that A-1 should cease activities that have resulted in the device being misbranded.
A-1 Engineering did not respond to a request for comment by press time.