FDA WARNING_LETTER - Quanta Systems, S.p.A. - April 19, 2012

On April 16-19, 2012, the FDA inspected Quanta Systems, S.p.A. in Solbiate Olona (VA), Italy, finding violations related to their Q-Plus C, Quanta System Q-Plus T, and Cyber TM 150 Thulium lasers.

Key violations include: 1. **Failure to adequately develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17).** The procedure lacked instructions for timely transmission of complete MDRs, including the 3500A form and submission address, and failed to describe documentation and record-keeping requirements for adverse events. While Quanta Systems developed a new MDR procedure, the FDA's initial assessment found it adequate. 2. **Promoting and distributing Quanta Q-Plus and Light Series Laser models without required clearance or approval.** The firm marketed devices for unapproved indications like skin rejuvenation, non-ablative collagen remodeling, and post-sclerotherapy matting, representing a major change in intended use without a Premarket Approval (PMA) or 510(k) notification. This renders the devices adulterated (Section 501(f)(1)(B)) and misbranded (Section 502(o)). 3. **Modifying treatment parameters and combining different wavelengths for Q-Plus and Light Series lasers