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

Source: https://www.keypedia.com/records/warning_letter/quanta-systems-spa/4f22b36a-3763-4ad8-99f7-12b8427e1c5f

> FDA WARNING_LETTER for Quanta Systems, S.p.A. on April 19, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Quanta Systems, S.p.A.
- Inspection Date: 2012-04-19
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.keypedia.com/companies/quanta-systems-spa/be453070-cba1-4826-8289-bdd28c4789db

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7