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

Source: https://www.keypedia.com/records/warning_letter/alma-lasers-inc/1b4994ff-8735-4d5b-b917-985d608fdbb3

> FDA WARNING_LETTER for Alma Lasers, Inc. on January 29, 2013. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Alma Lasers, Inc.
- Inspection Date: 2013-01-29
- Product Type: Devices
- Office Name: Chicago District Office
- Summary: 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record-keeping requirements for MDR event files, evaluation information, and decision-making processes, and contained outdated references to baseline reporting and annual certification.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

## Related Officers

- [Scott J. Macintire](https://www.keypedia.com/people/scott-j-macintire/ca3dc0d0-ffd3-4d61-bd98-56aa7d8b15af)

Company: https://www.keypedia.com/companies/alma-lasers-inc/663acc8c-d57b-4a90-85bc-c49390508b1f

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669