FDA WARNING_LETTER - A1 Engineering - March 18, 2015

On November 19, 2015, the FDA issued a Warning Letter to A-1 Engineering following an inspection from March 2-18, 2015, at their Rancho Cucamonga, California facility. The inspection revealed that the firm's Neurotris SX-Series Machines and Neurotris PICO Toner, classified as medical devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice requirements of the Quality System regulation (21 CFR Part 820). The firm had not responded to the FDA 483 issued after the inspection.

Key violations included: 1. Failure to maintain device master records (21 CFR 820.181), specifically for the Neurotris SX-Series Machines. 2. Failure to establish and maintain device history records (21 CFR 820.184), lacking procedures and complete documentation. 3. Failure to establish and maintain procedures for purchased products and services (21 CFR 820.50). 4. Failure to evaluate and document supplier evaluations (21 CFR 820.50(a)(1)). 5. Failure to maintain complaint files (21 CFR 820.198(a)), with undocumented investigation activities and retesting. 6.