FDA WARNING_LETTER - Alma Lasers, Inc. - January 29, 2013

The FDA conducted an inspection of Alma Lasers, Inc. from January 17-29, 2013, identifying the firm as an initial importer and manufacturer of Class II cosmetic lasers and thermotherapy systems. The inspection revealed the devices are misbranded and adulterated.

Key violations include: 1. **Failure to report serious injuries:** The firm failed to report a third-degree burn incident to the FDA within 30 days, as required by 21 CFR 803.50(a)(1). 2. **Inadequate MDR procedures:** The "Adverse events and Recall Procedure" (21 CFR 803.17) lacked definitions for reportable events, a standardized review process for determining reportability (including investigation instructions and decision-making authority), and instructions for timely transmission of complete reports (e.g., obtaining/completing FDA 3500A, submission address, circumstances for initial/supplemental/follow-up reports). It also failed to describe documentation and record-keeping requirements for MDR event files, evaluation information, and decision-making processes, and contained outdated references to baseline reporting and annual certification. 3. **Incomplete complaint investigation records:** Complaint records (21 CFR 820.198(e)) lacked crucial information such as skin test fluence, patient treatment outcomes, burn details, patient diagnoses, areas treated, medical treatment sought, patient